Consumer medicine information

CandaDerm

Hydrocortisone; Clotrimazole

BRAND INFORMATION

Brand name

CandaDerm

Active ingredient

Hydrocortisone; Clotrimazole

Schedule

SUMMARY CMI

CandaDerm

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CandaDerm?

CandaDerm contains the active ingredients clotrimazole and hydrocortisone. CandaDerm is used on the skin to treat and soothe inflamed fungal skin conditions such as tinea pedis (athlete's foot), external symptoms of thrush, jock itch, fungal infected nappy rash, ringworm, fungal skin rash and fungal infected eczema or dermatitis.

For more information, see Section 1. Why am I using CandaDerm? in the full CMI.

2. What should I know before I use CandaDerm?

Do not use if you have ever had an allergic reaction to CandaDerm or any of the ingredients listed at the end of the CMI.

Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use CandaDerm? in the full CMI.

3. What if I am taking other medicines?

It is not expected that CandaDerm will interfere with other medicines you might be using; however, you should always ask your practitioner, doctor or pharmacist if you have any concerns about using CandaDerm together with other medicines.

See Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CandaDerm?

A small amount of CandaDerm should be applied thinly and evenly with gentle rubbing to the affected area(s) twice daily until inflammation, itching and redness have subsided and not for more than 7 days (unless directed by a doctor); then use an antifungal-only cream for 14 days after symptoms disappear to avoid recurrence of the infection.

More instructions can be found in Section 4. How do I use CandaDerm? in the full CMI.

5. What should I know while using CandaDerm?

Things you should do	Remind any doctor, dentist, pharmacist or dermatologist you visit that you are using CandaDerm Tell your doctor if you are pregnant, are breast-feeding or intend to breast-feed while using CandaDerm In babies, take care not to fasten nappies too tightly over the treated area, as this may increase the chance of side effects
Things you should not do	Do not use CandaDerm in or near the eyes Do not use CandaDerm under dressings or in large areas on the skin unless your doctor tells you to Do not use large amounts of CandaDerm for a long time
Driving or using machines	Corticosteroid medicine can cause visual disturbance; make sure you know how you react to CandaDerm or that your vision is clear before driving a car or operating machinery
Looking after your medicine	Store it in a cool dry place below 30°C and away from moisture, heat or sunlight Discard contents 3 months after opening the tube

For more information, see Section 5. What should I know while using CandaDerm? in the full CMI.

6. Are there any side effects?

Less serious side effects are related to skin reactions: hypersensitivity reactions (slight stinging sensation after application of cream), burning/stinging, swelling, redness.

Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

CandaDerm

Active ingredients: clotrimazole and hydrocortisone

Consumer Medicine Information (CMI)

This leaflet provides important information about using CandaDerm. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CandaDerm.

Where to find information in this leaflet:

1. Why am I using CandaDerm?
2. What should I know before I use CandaDerm?
3. What if I am taking other medicines?
4. How do I use CandaDerm?
5. What should I know while using CandaDerm?
6. Are there any side effects?
7. Product details

1. Why am I using CandaDerm?

CandaDerm contains the active ingredients clotrimazole and hydrocortisone. CandaDerm is a broad spectrum anti-fungal and anti-inflammatory cream.

CandaDerm is used on the skin to treat and soothe inflamed fungal skin conditions such as:

Tinea pedis (athlete's foot)
External symptoms of thrush
Jock itch
Fungal infected nappy rash
Ringworm
Fungal skin rash
Fungal infected eczema or dermatitis.

2. What should I know before I use CandaDerm?

Warnings

Do not use CandaDerm if:

you are allergic to clotrimazole, hydrocortisone, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
the skin on the area to be treated is cracked or broken
you have a viral skin infection (such as cold sores, shingles or chicken pox)
you have other infections of the skin (such as acne, rosacea, perioral dermatitis, lues [syphilis], tuberculosis [which rarely can present as a skin infection, although normally a disease of the lungs]
you have a reaction of the skin resulting from a vaccination.

Do not apply CandaDerm just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of the cream.

Check with your doctor or pharmacist if you:

have any other medical conditions
take any medicines for any other condition
have cuts or abrasions at or near the area to be treated; the chance of unwanted effects may be increased.

Do not apply CandaDerm to large areas (more than 10% of the body surface) or under occlusive (air- and watertight) dressings, such as nappies and bandages. This may increase systemic absorption.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant. Your doctor will discuss with you the risks and benefits of using CandaDerm while you are pregnant.

Talk to your doctor or pharmacist if you are breast-feeding or intend to breast-feed. Your doctor will discuss with you the risks and benefits of using CandaDerm while you are breast-feeding.

CandaDerm should not be applied for a long period during pregnancy; therefore, CandaDerm should only be used in the first three months of pregnancy after first consulting your doctor.

Interactions with latex

The ingredients in CandaDerm cream may affect the latex used in barrier contraceptives such as condoms and diaphragms. You may need to use other methods of contraception whilst using this medicine and for at least 5 days after last using the cream.

Use in children

CandaDerm should only be used on children under 2 years of age (for example, fungal nappy rash) if a doctor has told you to. Bandages and some nappies that are air- and watertight (occlusive dressings) may increase absorption into the skin. This might be a risk in children, because they have a larger skin surface to body weight ratio than adults.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CandaDerm.

4. How do I use CandaDerm?

How much to use

Before use, pierce the seal on the tube by inverting the cap over the end of the tube and pressing
A small amount of CandaDerm should be applied thinly and evenly with gentle rubbing to the affected area(s)
Follow the instructions provided by your doctor or pharmacist carefully; these directions may differ from the information contained in this leaflet
If you do not understand the instructions in this leaflet, ask your pharmacist for help
DO NOT TAKE THIS CREAM BY MOUTH.

When to use CandaDerm

CandaDerm should be applied to the affected area(s) twice daily until inflammation, itching and redness have subsided and not for more than 7 days (unless directed by a doctor); then use an antifungal-only cream for 14 days after symptoms disappear to avoid recurrence of the infection
Using it more often than you should may not improve your skin problem any faster and may cause or increase side effects.

If you use too much CandaDerm

If you think that you have used too much CandaDerm, or you have swallowed CandaDerm cream, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre (by calling 13 11 26) (Australia) or the National Poisons Centre (by calling 0800 POISON [0800 764766]) (New Zealand), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using CandaDerm?

Things you should do

Tell your doctor if you are pregnant, are breast-feeding or intend to breast-feed while using CandaDerm.
In babies, take care not to fasten nappies too tightly over the treated area, as this may increase the chance of side effects.

Remind any doctor, dentist, pharmacist or dermatologist you visit that you are using CandaDerm.

Things you should not do

Do not use CandaDerm in or near the eyes; if you accidentally get CandaDerm in your eyes, rinse them well with water
Do not use CandaDerm under dressings or in large areas on the skin unless your doctor tells you to
Do not use large amounts of CandaDerm for a long time; if you use large amounts for a long time, the chance of absorption through the skin and side effects increase.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CandaDerm affects you.

Corticosteroid medicine can cause visual disturbance. Make sure you know how you react to CandaDerm or that your vision is clear before driving a car or operating machinery.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place below 30°C and away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

Discard contents 3 months after opening the tube.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

These can particularly occur:

after use on large areas (more than 10% of the body surface)
with long-term use (longer than 2 – 4 weeks)
under occlusive (air- and watertight) dressings.

Less serious side effects	What to do
Skin reactions: hypersensitivity reactions (slight stinging sensation after application of cream) burning/stinging swelling redness	Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration (Australia) online at www.tga.gov.au/reporting-problems or nzphvc.otago.ac.nz/reporting (New Zealand). By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What CandaDerm contains

Active ingredients (main ingredients)	Clotrimazole 1% w/w Hydrocortisone 1% w/w
Other ingredients (inactive ingredients)	Cetomacrogol 1000 (ceteareth-10) Cetostearyl alcohol Chlorocresol (as preservative) Glycerol Liquid paraffin Propylene glycol Purified water Whit soft paraffin

Do not take this medicine if you are allergic to any of these ingredients.

What CandaDerm looks like

CandaDerm is an opaque off-white viscous cream.

CandaDerm is filled into aluminium tubes with white plastic screw caps each containing 30 g of cream.

AUST R 240672.

Who distributes CandaDerm

In Australia:

AFT Pharmaceuticals Pty Ltd
113 Wicks Road
North Ryde
NSW 2113
Email: [email protected]
Freephone (AU): 1800 AFTPHARM (1800 238 74276)

In New Zealand:

AFT Pharmaceuticals Ltd
Level 1, 129 Hurstmere Road
Takapuna
Auckland, 0622
Email: [email protected]
Phone: 0800 423 823

This leaflet was prepared in October 2021.

Published by MIMS August 2025

BRAND INFORMATION

Brand name

CandaDerm

Active ingredient

Hydrocortisone; Clotrimazole

Schedule

1 Name of Medicine

Clotrimazole and hydrocortisone cream.

2 Qualitative and Quantitative Composition

CandaDerm contains 1% w/w (10 mg/g) of clotrimazole and 1% w/w (10 mg/g) of hydrocortisone as active ingredients.
Contains chlorocresol as preservative.
For the full list of excipients, see Section 6.1 List of Excipients.
Topical corticosteroid/antifungal. On topical application, corticosteroids (hydrocortisone) produce anti-inflammatory, antipruritic and vasoconstrictor actions. The activity of the drugs is thought to result at least in part from binding with a steroid receptor.
Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeast and Pityrosporum orbiculare. The antifungal action appears to be on the cell membrane of the fungi, damaging the permeability barrier.

3 Pharmaceutical Form

CandaDerm cream is an opaque off-white viscous cream.

4 Clinical Particulars

4.1 Therapeutic Indications

CandaDerm cream is indicated for dermatophyte and yeast infections of the skin when inflammation is prominent. This includes conditions such as fungal infected dermatitis, intertrigo and Candida nappy rash.

4.2 Dose and Method of Administration

Dose.

A small amount of CandaDerm cream should be applied twice daily.

Method of administration.

Apply thinly and evenly with gentle rubbing to the affected area(s). Use only until inflammation, itching and redness have subsided and not for more than 7 days (unless directed by a doctor). Then use an antifungal-only cream such as clotrimazole cream for 14 days after symptoms disappear to avoid recurrence of the infection.

4.3 Contraindications

CandaDerm cream is contraindicated in the following cases:
hypersensitivity to the active substances or to any of the excipients listed in Section 6.1 List of Excipients;
on broken skin;
diseases affecting the skin (such as acne, rosacea, perioral dermatitis, lues, tuberculosis, etc.);
in or near the eyes;
viral skin diseases (e.g. herpes simplex, chicken pox, etc.);
dermal vaccination reactions.

4.4 Special Warnings and Precautions for Use

For external use only. Avoid contact with eyes. Do not swallow. Keep this medicine out of the reach of children.
Because of its corticosteroid content, CandaDerm cream should not be applied:
to large areas (more than 10% of the body surface); and/or
under occlusive dressings (such as nappies and bandages) because this may increase absorption.
Cetostearyl alcohol, which is an excipient in this medicine, may cause local skin reactions (e.g. contact dermatitis).

Interactions with latex.

The effectiveness and safety of latex products such as condoms and diaphragms may be reduced by CandaDerm cream when applied on the genital area (women: labia and adjacent area of the vulva; men: prepuce and glans of the penis). The effect is temporary and may occur only during treatment. If an associated infection develops during use and does not respond to therapy, use should be discontinued until the infection is controlled.

Hypothalamic-pituitary axis suppression and atrophic striae.

Long term corticosteroid use may increase the risk of hypothalamic-pituitary axis suppression, especially under occlusion. Use for longer than 4 weeks can cause atrophic striae and prolonged use on flexures and in intertriginous areas is undesirable.

Use in the elderly.

No data available.

Paediatric use.

The risk of systemic absorption, and hence systemic toxicity, is greater in children due to the higher permeation properties of the skin and a larger skin surface to body weight ratio than adults. Do not use on children under 2 years of age except on the advice of a doctor.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Not known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No human studies of the effects of clotrimazole on fertility have been performed, however animal studies have not demonstrated any effects of the medicine on fertility.
No data is available on the effects of topically applied hydrocortisone.
(Category A)
There is a limited amount of data from the use of clotrimazole or hydrocortisone in pregnant women. Animal studies with clotrimazole do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Section 5.3 Preclinical Safety Data). Studies in animals have shown reproductive effects at high doses of corticosteroids after systemic use (see Section 5.3 Preclinical Safety Data), and there is no animal data on the reproductive effects after topical use. As a precautionary measure, it is recommended not to apply CandaDerm for a long period during pregnancy, particularly in the first three months, and it is preferable to avoid the use of CandaDerm cream during the first trimester of pregnancy.
[Category A: Medicines which have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.]
Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole and/or metabolites in milk after intravenous administration (see Section 5.3 Preclinical Safety Data).
No data on hydrocortisone is available, but topically applied hydrocortisone is unlikely to cause systemic effects due to the low percutaneous penetration. However, cutaneous absorption may be increased under certain circumstances, such as with use of occlusive dressings, the degree of skin damage and the size of the treated area.
Administration of CandaDerm during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant. If used during lactation, CandaDerm should not be applied to the breasts to avoid accidental ingestion by the infant.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions have been identified during post-approval use of CandaDerm. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Immune system disorders.

Allergic reaction (syncope, hypotension, dyspnoea, urticaria).

Skin and subcutaneous tissue disorders.

Discomfort/pain, oedema, erythema, hypertrichosis, irritation, pruritus, rash, secondary infections and acneiform symptoms, skin atrophy, skin discolouration, skin striae, stinging/burning, telangiectasis.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

No reports are available on cases of overdosage with CandaDerm cream.
No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.
Excessive chronic exposure results in adverse systemic and dermal effects. In such cases, the use of topical corticosteroid should be discontinued, with consideration given to tapering the dose.
For more information and advice on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clotrimazole.

Synthetic imidazole derivative with broad spectrum antifungal activity and some antibacterial activity. It exerts its antifungal activity by altering cell membrane permeability by interfering with ergosterol synthesis. The cell membrane is unable to function as a selective barrier, and potassium and other cellular constituents are lost.
In vitro, clotrimazole concentrations of 1 microgram/mL or less inhibit most strains of Trichophyton rubrum, T. mentagrophytes, Epidermophyton floccosum and Microsporum canis. At a concentration of 3 microgram/mL or less, clotrimazole inhibits most other susceptible organisms including Pitysporum orbiculare, Aspergillus fumigatus and a few strains of Proteus vulgaris and Salmonella.

Hydrocortisone.

Corticosteroid in general, decreases inflammation by stabilising leucocyte lysosomal membranes, preventing the release of the destructive contents from leucocytes, inhibiting macrophage accumulation in inflamed areas, reducing leucocyte adhesion to the capillary endothelium, reducing capillary wall permeability and oedema formation, decreasing complement components, antagonising histamine activity and release of kinin from substrates, reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation, and possibly by other mechanisms as yet unknown.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Clotrimazole.

Studies of urinary excretion have shown that less than 0.5% of dermally applied clotrimazole appears in the urine over a five-day period of observation. Faecal excretion, the route by which most of the absorbed drug is likely to be eliminated, has not been studied in humans.

Hydrocortisone.

The rate and extent of hydrocortisone absorption through the skin varies among individual patients.
Absorption is, however, markedly increased when the skin has lost its keratin layer or the rate limiting properties of the stratum corneum. Physical disruption of the stratum corneum, inflammation and/or disease to the epidermal barrier (e.g. psoriasis, eczema) may result in increased absorption.
Hydrocortisone is absorbed to a greater degree from the skin of the ear region (around and behind), scrotum, axilla, eyelid, face and scalp than from the skin of the forearm, knee, elbow, palm and sole. Prolonged absorption persists even after the area of application has been washed, possibly because the drug is retained in the stratum corneum and/or the dermoepidermal layer.
Hydrocortisone is metabolised by the liver and most other tissues to hydrogenated and degraded forms (such as tetrahydrocortisone and tetrahydrocortisol).
The metabolites of hydrocortisone are excreted in urine mainly conjugated as glucoronides, together with a very small proportion of unchanged hydrocortisone. The biological half-life is approximately 100 minutes.

5.3 Preclinical Safety Data

Clotrimazole.

Toxicological studies in different animals with local or intravaginal application showed good local and vaginal tolerability. Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and toxicity to reproduction.

Hydrocortisone.

As an adrenocortical hormone, hydrocortisone is classified as relatively non-toxic on topical use. So far there is no evidence of any reproduction toxicity for corticoids used topically in accordance with the instructions.

Genotoxicity.

Clotrimazole.

Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity.

Hydrocortisone.

Teratogenic effects of high doses of glucocorticosteroids such as cleft palate formation, growth retardation, etc. are known after systemic use in animal studies; there are no data on teratogenic damage after dermal use. Years of therapeutic experience in man with topical use of hydrocortisone have not yielded any evidence of teratogenicity.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cetomacrogol 1000, cetostearyl alcohol, glycerol, liquid paraffin, propylene glycol, soft white paraffin, purified water, chlorocresol (as preservative).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
CandaDerm has a shelf life of 3 months once opened.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

CandaDerm filled into aluminium tubes with an inner lacquer and white polyethylene screw cap containing 30 g of cream.

6.6 Special Precautions for Disposal

CandaDerm should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Clotrimazole.

It is a colourless, crystalline, weakly alkaline substance, soluble in acetone, chloroform and ethanol and practically insoluble in water. It forms stable salts with both organic and inorganic acids. It is not photosensitive but it is slightly hygroscopic, and may be hydrolysed in acid media.

Chemical name: 1-[(2-chlorophenyl)(diphenyl)methyl]-1H-imidazole.
Molecular formula: C₂₂H₁₇ClN₂.
Molecular weight: 344.84.
Melting point: 141 - 145°C.

Hydrocortisone.

Hydrocortisone is an odourless, white or almost white crystalline powder. It is practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly soluble in methylene chloride, very slightly soluble in ether.

Chemical name: (11β)-11,17,21-trihydroxypregn-4-ene-3,20-dione.
Molecular formula: C₂₁H₃₀O₅.
Molecular weight: 362.5.

CAS number.

Clotrimazole.

23593-75-1.

Hydrocortisone.

50-23-7.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Service Unavailable

Consumer medicine information

CandaDerm

Hydrocortisone; Clotrimazole

Keep track of your medicines

BRAND INFORMATION