Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about DermAid Soft 1% cream.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What is DermAid Soft 1% cream

The name of your medicine is DermAid Soft 1% cream. It is a soft, glossy cream.

DermAid Soft 1% cream contains hydrocortisone at 1 %w/w.

DermAid Soft 1% cream is available in 15 g and 30 g tubes. It is packed in tubes with a tamper evident seal for your protection. Do not use if the seal on the tube is broken.

What DermAid Soft 1% cream is used for

DermAid Soft 1% cream is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as:

• eczema
• rashes due to soap, detergent, cosmetics and jewellery
• itching genital and anal areas not due to infection
• sunburn
• other types of dermatitis

Your doctor or pharmacist, however, may have recommended DermAid Soft 1% cream for another purpose.

How it works

The active ingredient in DermAid Soft 1% cream, hydrocortisone, reduces inflammation and itching. It is used for the relief of symptoms associated with conditions such as dermatitis, eczema and psoriasis.

Before using DermAid Soft 1% cream

Contraindications (when you must not use this product)

Do not use DermAid Soft 1% cream in the eyes.

Do not use DermAid Soft 1% cream for acne.

Do not use DermAid Soft 1% cream if you have ever had an allergic reaction to:

• hydrocortisone
• any other corticosteroid
• phenethyl alcohol

Do not use DermAid Soft 1% cream if you have:

• a viral skin infection (such as cold sores, shingles or chicken pox)
• a fungal skin infection (such as thrush, tinea or ringworm)
• a bacterial skin infection (such as impetigo or boils) unless your doctor or pharmacist tells you.

Precautions

DermAid Soft 1% cream reduces inflammation and itching. As a result, signs of infection may be masked. The area being treated should be kept clean at all times. If there is a possibility of infection in the area being treated then the infection should be controlled first. You should consult your doctor or pharmacist for advice.

Do not use under occlusion (plastic film) unless specified by your doctor.

Be careful not to get DermAid Soft 1% cream in your eyes. If this happens rinse your eyes with clean water. If irritation persists tell your doctor or pharmacist.

If irritation or sensitivity occurs discontinue use.

Interactions

Tell your doctor or pharmacist if you are using other creams, ointments or lotions or taking any medicine.

Pregnancy and lactation

You must tell your doctor if you are pregnant or breast-feeding. Your doctor will tell you if you can use DermAid Soft 1% cream during pregnancy or while you are breast-feeding. DermAid Soft 1% cream should not be applied to breasts before breast-feeding.

Use in children

Do not use DermAid Soft 1% cream on children under 2 years of age unless your doctor tells you.

How to use DermAid Soft 1% cream

Directions

DermAid Soft 1% cream is for external use only.

Apply a thin layer of DermAid Soft 1% cream to your skin 2 to 4 times a day.

Your doctor or pharmacist may have recommended a different dosage. It is important to use DermAid Soft 1% cream exactly as your doctor or pharmacist has told you. If you use it less often 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.

If you have dry skin you may find an emollient such as "QV Cream" provides further relief between applications of DermAid Soft 1% cream. Apply "QV Cream" as often as required.

How long to use it

If your condition persists for more than 7 days then discontinue use and see your doctor or pharmacist.

If you forget to use it

If you forget to use DermAid Soft 1% cream, use it as soon as you remember and then go back to your normal times for applying DermAid Soft 1% cream. Do not try to make up for the amount you missed by using more than you would normally use.

Side effects

DermAid Soft 1% cream helps most people with skin problems but it may have unwanted side effects in a few people.

Side effects that have been reported by some people using cortisones include:

• slight stinging sensation
• itching
• redness
• allergy
• thinning of the skin
• blurred vision or other vision disturbances

If you have these or any other side effects, check with your doctor or pharmacist.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Overdosage

If you have accidentally applied too much DermAid Soft 1% cream, then wipe off any excess.

If you swallow it

Telephone your Poisons Information Centre (13 11 26 in Australia or 03 474 7000 in New Zealand), or contact your doctor or pharmacist.

Storage

Keep DermAid Soft 1% 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 DermAid Soft 1% cream in a cool dry place where the temperature stays below 25 degrees C.

Do not leave DermAid Soft 1% cream in the car or on windowsills.

Heat can destroy some medicines.

Shelf life

Do not use DermAid Soft 1% cream after the expiry date printed on the pack. If you use it after the expiry date has passed, it may not work as well.

For further information

This is not all the information that is available on DermAid Soft 1% cream.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Manufacturer

Ego Pharmaceuticals Pty. Ltd.
21-31 Malcolm Road, Braeside, 3195
Australia

Distributors

NEW ZEALAND

Douglas Pharmaceuticals Ltd
PO Box 45027, Auckland 8
New Zealand

'Ego' and 'DermAid' are trade marks of Ego Pharmaceuticals Pty Ltd

Date of last revision: April 2019.

Published by MIMS September 2019

1 Name of Medicine

Hydrocortisone.

2 Qualitative and Quantitative Composition

DermAid Soft 1% cream.

DermAid Soft 0.5% cream.

3 Pharmaceutical Form

DermAid Soft Cream is a soft cream for topical application.

4 Clinical Particulars

4.1 Therapeutic Indications

DermAid Soft Cream is indicated for topical application for the temporary relief of symptoms associated with acute and chronic corticosteroid responsive conditions, including minor skin irritations, itching and rashes due to eczema, dermatitis, contact dermatitis (such as rashes due to soap, detergent, cosmetics and jewellery), psoriasis, non-infected anogenital pruritus, and sunburn.

4.2 Dose and Method of Administration

A thin layer should be applied to the affected skin two to four times a day. Once the inflammation has subsided the frequency of may be reduced.

4.3 Contraindications

Acne.
Hypersensitivity to any of the ingredients.
Do not use in the eye.
Like all other topical corticosteroids, DermAid Soft Cream is contraindicated in skin infections and infestations such as chickenpox, herpes and other viral infections.
Hydrocortisone may mask signs of infection. If any infection is present, an appropriate anti-infective agent should be used first. DermAid Soft 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 the depression of the hypothalamo-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

Long-term continuous topical therapy should be avoided where possible, particularly in children, as adrenal suppression can occur (even without occlusion).
As with other topical corticosteroids, when extensive areas are treated, sufficient systemic absorption may occur to produce the features of hypercorticalism. This effect is more likely to result if occlusive dressings are used or if treatment is prolonged. Rarely, local atrophy or striae may occur after prolonged treatment. This must be borne in mind when treating conditions such as severe eczema and seborrhoeic dermatitis. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye as glaucoma may result. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions that have become infected.
Topical corticosteroids should be used with caution in patients with primary skin infections. Any spread of the infection requires withdrawal of corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions associated with occlusive dressings, so the skin should be cleansed prior to a fresh dressing being applied.
Patients in whom there is a risk of increased systemic absorption should be regularly evaluated for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression by using urinary free cortisol (hydrocortisone) tests and monitoring morning plasma cortisol levels.
If there is evidence of suppression, attempts should be made to withdraw the drug or reduce the frequency of application. If hypersensitivity occurs, stop application and institute appropriate therapy. If irritation occurs, discontinue use. Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if occlusion is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated.
Withdrawal of corticosteroid therapy may exacerbate psoriasis. The frequency of application should be reduced before withdrawing the therapy. Therapy may be continued with a milder preparation such as Egoderm cream or ointment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Visual disturbance.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interactions known.

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)

After the application of DermAid Soft Cream a slight stinging sensation may occasionally be noticed. This transient symptom is most likely to disappear after several applications.
Intolerance to the occlusive dressing (miliary eruptions, folliculitis) may be expected to be observed, as with other corticosteroids. In such cases the use of an occlusive dressing should be discontinued. Use of the steroid may also need to be reduced or discontinued as local atrophy and striae of the skin may be observed.
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.
Systemic adverse reactions, such as blurred vision, have also been reported with the use of topical corticosteroids.

Reporting suspected adverse effects.

4.9 Overdose

Percutaneous absorption of corticosteroids may occur, especially under occlusive conditions. The following adverse effects have been reported with topical steroids: burning; itching; irritation; skin atrophy; secondary infection; dryness; acnederm eruptions and hypopigmentation. Treatment should be chiefly symptomatic and administration of the steroid should be discontinued.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each gram of DermAid Soft Cream contains hydrocortisone (10 mg/g or 5 mg/g, as appropriate) in a soft cream base of 1,3-butylene glycol, cetostearyl alcohol, citric acid, dimeticone 350, disodium edetate, self-emulsifying glyceryl monostearate, light liquid paraffin, PEG-40 stearate, povidone, dibasic sodium phosphate, purified water, xanthan gum and phenethyl alcohol (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.

6.4 Special Precautions for Storage

DermAid 0.5% cream.

DermAid 1% cream.

6.5 Nature and Contents of Container

DermAid Soft 0.5% cream.

DermAid Soft 1% 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

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S2 (0.5%); S3 (1%).

Summary Table of Changes