SUMMARY CMI

CHEMISTS' OWN SKIN IRRITATION CREAM

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 CHEMISTS' OWN SKIN IRRITATION CREAM?

CHEMISTS' OWN SKIN IRRITATION CREAM contains the active ingredient hydrocortisone acetate. CHEMISTS' OWN SKIN IRRITATION CREAM is a topical corticosteroid therapy for non-infected inflammatory conditions of the skin. CHEMISTS' OWN SKIN IRRITATION CREAM is used on the skin to relieve the redness, swelling, itching and discomfort of skin problems such as rashes due to eczema, dermatitis, soap, detergent, cosmetics, jewellery, insect bites, itching anal and genital areas not due to infection, and sunburn.

For more information, see Section 1. Why am I using CHEMISTS' OWN SKIN IRRITATION CREAM? in the full CMI.

2. What should I know before I use CHEMISTS' OWN SKIN IRRITATION CREAM?

Do not use if you have ever had an allergic reaction to hydrocortisone acetate 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 CHEMISTS' OWN SKIN IRRITATION CREAM? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CHEMISTS' OWN SKIN IRRITATION CREAM and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CHEMISTS' OWN SKIN IRRITATION CREAM?

• Apply a thin layer to affected areas two to four times a day or as directed.
• Rub in gently. Reduce the number of applications as the disorder subsides.

More instructions can be found in Section 4. How do I use CHEMISTS' OWN SKIN IRRITATION CREAM? in the full CMI.

5. What should I know while using CHEMISTS' OWN SKIN IRRITATION CREAM?

For more information, see Section 5. What should I know while using CHEMISTS' OWN SKIN IRRITATION CREAM? in the full CMI.

6. Are there any side effects?

Common side effects include itching, burning, dryness and acne-form eruptions. Prolonged or over-use of this medicine may cause other side effects including high blood pressure.

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

CHEMISTS' OWN SKIN IRRITATION CREAM

Active ingredient: hydrocortisone acetate

Consumer Medicine Information (CMI)

This leaflet provides important information about using CHEMISTS' OWN SKIN IRRITATION CREAM. 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 CHEMISTS' OWN SKIN IRRITATION CREAM.

Where to find information in this leaflet:

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

1. Why am I using CHEMISTS' OWN SKIN IRRITATION CREAM?

CHEMISTS' OWN SKIN IRRITATION CREAM contains the active ingredient hydrocortisone acetate. CHEMISTS' OWN SKIN IRRITATION CREAM is a type of cortisone and belongs to the group of medicines called corticosteroids. It is available as a cream. CHEMISTS' OWN SKIN IRRITATION CREAM is used for non-infective inflammatory conditions of the skin e.g. eczema, dermatitis.

CHEMISTS' OWN SKIN IRRITATION CREAM is used on the skin to relieve the redness, swelling, itching and discomfort of skin problems such as rashes due to eczema, dermatitis, soap, detergent, cosmetics, jewellery, insect bites, itching anal and genital areas not due to infection, and sunburn.

2. What should I know before I use CHEMISTS' OWN SKIN IRRITATION CREAM

Warnings

Do not use CHEMISTS' OWN SKIN IRRITATION CREAM if you:

• are allergic to hydrocortisone acetate, or any of the ingredients listed at the end of this leaflet.
• have untreated bacterial infections
• have parasitic skin infections (such as scabies)
• have a viral skin infection (such as herpes simplex, cold sores, shingles or chicken pox)
• have tuberculous conditions of the skin
• have vaccinia (cowpox: a viral disease passed from cattle)
• have varicella (a rare form of chicken pox)
• have acne or rosacea
• have cuts or open wounds

Do not use CHEMISTS' OWN SKIN IRRITATION CREAM on psoriasis unless recommended by your doctor

CHEMISTS' OWN SKIN IRRITATION CREAM should not be used if you suffer from poor circulation of blood in the skin region, as it may result in skin ulcers.

Do not use occlusive dressings or waterproof bandages unless a doctor has told you to.

Check with your doctor or pharmacist to be sure that you do not have any of these conditions.

Do not use CHEMISTS' OWN SKIN IRRITATION CREAM after the expiry date printed on the pack.

It may have no effect at all, or worse, it may give an entirely unexpected effect if you use after the expiry date.

Do not use CHEMISTS' OWN SKIN IRRITATION CREAM if the packaging shows sign of tampering or the seal on the tube is broken, or if the product does not look quite right.

Check your doctor or pharmacist to be sure that you do not

• have any other medical conditions such as diabetes or problems with your immune system
• have serious eye conditions including cataract, glaucoma or central serous chorioretinopathy (CSCR).
• have any other health problems.

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.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

If CHEMISTS' OWN SKIN IRRITATION CREAM is to be applied to the breast, do not apply the cream to the breast before breast feeding. Ensure that the breast area is free of the cream before breastfeeding.

Use in children

Do not use in children under 2 years unless your doctor tells you to do so.

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.

Some medicines may interfere with CHEMISTS' OWN SKIN IRRITATION CREAM if it is used excessively or for prolonged periods. Some of these medicines include medicines to treat epilepsy, diuretics, oral contraceptive pills and immunosuppressants.

Your doctor or pharmacist has a list of medicines that may interfere with CHEMISTS' OWN SKIN IRRITATION CREAM.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CHEMISTS' OWN SKIN IRRITATION CREAM.

4. How do I use CHEMISTS' OWN SKIN IRRITATION CREAM?

How much to use

• Apply a thin layer to affected areas two to four times a day or as directed. Rub in gently. Reduce the number of applications as the disorder subsides.
• Do not apply this cream under occlusive dressings or waterproof bandages unless on the advice of a doctor.
• It is important to use CHEMISTS' OWN SKIN IRRITATION CREAM exactly as your doctor (or pharmacist) has told you.
• If you use it less than you should, it may not work as well and your skin problem may not improve.
• Using it more often than you should may not improve your skin problem any faster and may cause or increase side effects.

When to use CHEMISTS' OWN SKIN IRRITATION CREAM

• CHEMISTS' OWN SKIN IRRITATION CREAM at the same time every day.

How long to use it

• Do not use CHEMISTS' OWN SKIN IRRITATION CREAM for more than 7 days except on the advice of a doctor. If your condition persists, see your pharmacist or doctor.
  Reduce the number of applications as the disorder subsides. If you use CHEMISTS' OWN SKIN IRRITATION CREAM for a long time, the chance of side effects increases.

If you forget to use it

If you forget to use CHEMISTS' OWN SKIN IRRITATION CREAM, use it as soon as you remember and then go back to your normal times for applying CHEMISTS' OWN SKIN IRRITATION CREAM.

Do not try to make up for the amount you missed by using more than you normally use.

If you swallow or use too much CHEMISTS' OWN SKIN IRRITATION CREAM

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), 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 CHEMISTS' OWN SKIN IRRITATION CREAM?

Things you should do

• Tell all your doctors and pharmacists who are treating you that you are using CHEMISTS' OWN SKIN IRRITATION CREAM.
• Tell your doctor if you feel that CHEMISTS' OWN SKIN IRRITATION CREAM is not helping your condition.
• Tell your doctor if you become pregnant while using CHEMISTS' OWN SKIN IRRITATION CREAM.

Things you should not do

• Do not use CHEMISTS' OWN SKIN IRRITATION CREAM under dressings or on large areas of skin unless your doctor tells you.
• Do not use CHEMISTS' OWN SKIN IRRITATION CREAM in or near the eyes.
• Do not give CHEMISTS' OWN SKIN IRRITATION CREAM to anyone else even if their symptoms seem similar to yours.
• Do not use CHEMISTS' OWN SKIN IRRITATION CREAM to treat other conditions unless your doctor tells you.

Your doctor or pharmacist has recommended CHEMISTS' OWN SKIN IRRITATION CREAM especially for you and your condition. If you use it for another condition, it may not work or make the condition worse.

Things to be careful of

• Do not use large amounts of CHEMISTS' OWN SKIN IRRITATION CREAM for a long time.
• If you use large amounts for long time, the chance of systemic absorption through the skin and the chance of side effects increase.
• Ask your doctor (or pharmacist) if you are concerned about the length of time you have been using CHEMISTS' OWN SKIN IRRITATION CREAM.
• Only use CHEMISTS' OWN SKIN IRRITATION CREAM under the arm or in the groin if your doctor tells you.

Looking after your medicine

• Keep CHEMISTS' OWN SKIN IRRITATION CREAM where young children cannot reach it.
• A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
• Keep CHEMISTS' OWN SKIN IRRITATION CREAM in a cool dry place where the temperature stays below 25°C.
• Do not leave CHEMISTS' OWN SKIN IRRITATION CREAM in the car or on windowsills.
  Heat can destroy some medicines.

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

Serious side effects

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 online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

What CHEMISTS' OWN SKIN IRRITATION CREAM contains

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

What CHEMISTS' OWN SKIN IRRITATION CREAM looks like

CHEMISTS' OWN SKIN IRRITATION CREAM is a soft white cream.

CHEMISTS' OWN SKIN IRRITATION CREAM is packed in 30g tubes.

CHEMISTS' OWN SKIN IRRITATION CREAM

AUST R 284795

Who distributes CHEMISTS' OWN SKIN IRRITATION CREAM

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121

www.arrotex.com.au

This leaflet was prepared in March 2025.

Published by MIMS April 2025

1 Name of Medicine

Hydrocortisone acetate.

2 Qualitative and Quantitative Composition

Chemists' Own Skin Irritation Cream contains 1.0% w/w hydrocortisone acetate: 30 g tube.
Hydrocortisone acetate is an odourless, white or almost white, crystalline powder. Hydrocortisone acetate 112 mg is approximately equivalent to 100 mg of hydrocortisone.
Practically insoluble in water and in ether, soluble in ethanol (1 in 230) and in chloroform (1 in 200).

3 Pharmaceutical Form

Chemists' Own Skin Irritation Cream is a soft white cream with a faint odour of chlorocresol. It contains 1.0% w/w microfine hydrocortisone acetate in a water miscible, lanolin free cetomacrogol base. Chlorocresol 0.1% w/w is used as a preservative.

4 Clinical Particulars

4.1 Therapeutic Indications

Topical corticosteroid therapy for the temporary relief of symptoms of non-infected inflammatory conditions of the skin (e.g. minor skin irritations, itching and rashes due to eczema, dermatitis, contact dermatitis [such as rashes due to soap, detergent, cosmetics and jewellery], insect bites, itching anal and genital areas and sunburn).

4.2 Dose and Method of Administration

Adults and children from 2 years of age: apply a thin layer to affected areas 2-4 times daily. Reduce the number of applications as the disorder subsides. The cream should not be used under occlusive dressings or waterproof bandages unless advised to by a doctor. This preparation should not be used for more than 7 days except on the advice of a doctor. Rub in gently.

4.3 Contraindications

Tuberculous and fungal conditions of the skin, acute Herpes simplex, vaccinia, varicella and all viral infections.
Untreated bacterial infections.
Parasitic infestations (e.g. scabies).
In patients with markedly impaired circulations since skin ulceration has occurred in these patients following the use of corticosteroids.
Hypersensitivity to any component of the cream.
Not to be used in the eyes.
Not to be used for acne or rosacea.
The cream should not be used under occlusive dressings or waterproof bandages unless advised to by a doctor.
Hydrocortisone may mask signs of infection. If any infection is present, an appropriate anti-infective agent should be used first. Chemists' Own Skin Irritation Cream may be used to reduce inflammation but if a favourable response does not occur promptly then use of the product should be discontinued until the infection has been adequately controlled.
If any skin irritation develops, discontinue use and treat appropriately. If extensive areas are treated, or if occlusive dressings are used, the possibility also exists for increased systemic absorption and this could in turn lead to depression of the hypothalamic pituitary adrenal axis. In all such patients it is essential to monitor adrenal function at regular intervals.

4.4 Special Warnings and Precautions for Use

For external use only. Avoid contact with eyes.
This medicine should not be used in the eyes. Use of the cream near the eyes should be avoided. This is due to the risk of corticosteroid-induced open-angle glaucoma.
As with other topical corticosteroids, when extensive areas are treated, sufficient systemic absorption may occur to produce the features of hypercorticalism. Rarely, local atrophy or striae may occur after prolonged treatment. This must be borne in mind when treating conditions such as severe eczema and seborrheic dermatitis. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions that have become infected.
If irritation develops Chemists' Own Skin Irritation Cream should be discontinued and alternative therapy instituted. Prolonged and heavy doses of hydrocortisone may have an immunosuppressant effect and thus decrease resistance to infection as well as mask signs of it. If infection of the skin is present suitable antifungal or antibacterial agents should be used first. Any occlusive dressings should be discontinued. If the infection does not respond promptly to therapy, corticosteroid therapy should be discontinued until the infection has been controlled.
Where very large areas are treated for long periods (e.g. atopic dermatitis), the possibility of systemic absorption exists, particularly if an occlusive dressing is applied. Prolonged use of large quantities of topical corticosteroids may also result in atrophic striae or acne eruptions.
Due to the possible systemic absorption of topical steroids, there may be a need for periodic evaluation of hypothalamo-pituitary-adrenal (HPA)-axis suppression by using the urinary free cortisol test or the corticotrophin stimulation test. If the HPA-axis suppression is evident, withdrawal should be attempted and the frequency of application reduced.
Manifestations of adrenal suppression in children include retardation of linear growth, delayed weight gain, low plasma cortisol concentrations and lack of response to corticotrophin stimulation (see Section 5.2 Pharmacokinetic Properties). Manifestations of intracranial hypertension include bulging fontanelles, headache, and bilateral papilloedema. Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development. Parents should be advised not to use tight-fitting nappies or plastic pants on a child being treated in the diaper area, since such garments may constitute occlusive dressings.
Children have a greater surface to mass ratio than adults, and so may be at greater risk of adverse events from increased dosages.
Any corticosteroid therapy tends to elevate blood glucose levels in diabetic patients, and this should be monitored during treatment.
Corticosteroids should be used cautiously in patients with non-specific ulcerative colitis, diverticulitis, colon abscess or other pyogenic infection, colon obstruction, or extensive fistulas and sinus tracts, fresh intestinal anastomoses, active or latent peptic ulcers, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.
Topical corticosteroids should be used with caution in the management of psoriasis, as exacerbation of the disease or pustular psoriasis may occur during or on withdrawal of topical corticosteroid therapy.
Topical corticosteroids should also be used with caution in patients with impaired T cell function or in those patients receiving other immunosuppressive therapy. The immunosuppressive effects of corticosteroids may be associated with impairment of the normal function of T cells and macrophages. The result of this impairment may be the activation of latent infection or exacerbation of intercurrent infections, including those caused by Candida, Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia and Amoeba.
Patients on long term therapy, if there is a risk of immunosuppression, should not be given any live attenuated vaccines.
If hypersensitivity occurs, stop application and institute appropriate therapy.

Visual disturbance.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are many potential drug interactions with hydrocortisone, however most are quite unlikely with topical therapy, occurring mainly with prolonged or over-use.
Carbamazepine, phenytoin and rifampicin all induce hepatic enzymes and thus lead to increased metabolism of hydrocortisone.
Concomitant use of diuretics, which also deplete potassium ion concentration in the blood, may cause hypokalaemia.
All corticosteroids antagonise the effects of neuromuscular blocking agents, such as vecuronium.
Oral contraceptives have been shown to prolong the half-life of hydrocortisone and thus potentiate its anti-inflammatory effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

An itching or burning sensation may be experienced when using this medication.
Topical corticosteroids may cause adverse dermatological effects. Adverse dermatological effects are most likely to occur in intertriginous and facial areas. Local adverse corticosteroid effects occur most frequently with occlusive dressings, especially with prolonged therapy, and may require discontinuation of the dressings. Atrophy of the epidermis, subcutaneous tissue and dermal collagen; drying and cracking or tightening of the skin may occur. Epidermal thinning, telangiectasia, increased fragility of cutaneous blood vessels, purpura and atrophic striae are also reported.
Other adverse dermatologic effects of topical corticosteroids include acneiform eruption, vesiculation, irritation, pruritus, hypertrichosis, rosacea-like eruptions on the face, erythema, hyperesthesia, perioral dermatitis, burning or stinging sensation, folliculitis, and hypopigmentation.
Adverse dermatological effects usually improve when the drug is discontinued but may persist for long periods; atrophic striae may be permanent. In addition to the other adverse dermatological effects of topical corticosteroid therapy, maceration of the skin and miliaria may occur, especially when occlusive dressings are used. Topically applied steroids are generally nonsensitising, but allergic contact dermatitis may occur rarely.
Topical corticosteroids should be used with caution in the management of psoriasis (see Section 4.4 Special Warnings and Precautions for Use).
Topical corticosteroids should also be used with caution in patients with impaired T cell function or in those patients receiving other immunosuppressive therapy. The result of this impairment may be the activation of latent infection or exacerbation of intercurrent infections (see Section 4.4 Special Warnings and Precautions for Use).
Any cardiovascular adverse events are unlikely with topical hydrocortisone therapy, however, prolonged prolific use may result in a transient hypertension as a result of fluid retention.
Long term corticosteroid use has resulted in Benign lntracranial Hypertension, with most reports occurring in children.
Corticosteroids have documented effects on serum lipids, including increased total cholesterol, increased low density lipoproteins and increased triglyceride levels.
Topical and systemic corticosteroid therapy has been implicated in posterior subcapsular cataract formation, elevated intraocular pressure, optic nerve damage and papilloedema.
Cataracts, although primarily reported with systemic corticosteroid use, have been reported with use of topical preparations.
Hydrocortisone has least potential for causing glaucoma, but reports have demonstrated this complication in patients using topical preparations on the face.
In long-term treatment of extensive skin areas with occlusive dressings, one should bear in mind the possibility of inhibition of adrenal function. Therefore, adrenal function should be monitored under these circumstances.

Post marketing.

Eye disorders.

Reporting suspected adverse effects.

4.9 Overdose

Acute ingestion or accidental poisoning, even in massive doses, is rarely a clinical problem. Treatment should be symptomatic and supportive. Excessive chronic exposure results in adverse systemic effects. In such cases the use of topical corticosteroid should be discontinued, with the consideration to tapering the dose. Emesis or activated charcoal is not usually indicated unless multiple ingestion is suspected. Support the patient as necessary and treat symptomatically.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

The rate and extent of hydrocortisone absorption through the skin varies among individual patients. Following topical application of a corticosteroid to most areas of normal skin, only minimal amounts of the lipophilic drug partitions into the predominantly aqueous dermo-epidermal layer (viable epidermis + dermis) and subsequently the systemic circulation.

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The inactive ingredients are: soft white paraffin, liquid paraffin, cetomacrogol 1000, cetostearyl alcohol, chlorocresol, citric acid, sodium citrate dihydrate and purified water.

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.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Epoxy-coated Al tube contains 30 g of hydrocortisone acetate 10 mg/g cream.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Hydrocortisone is a corticosteroid and chemically described as 17-hydroxycorticosterone or 11,17,21-Trihydroxypregn-4-ene-3,20-dione. Hydrocortisone acetate is chemically described as hydrocortisone 21-acetate.
The molecular formula of hydrocortisone acetate is C₂₃H₃₂O₆.
The molecular weight of hydrocortisone acetate is 404.5.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Summary Table of Changes