Hioxyl Cream ()

1. Name Of The Medicinal Product

HIOXYL CREAM

2. Qualitative And Quantitative Composition

Hydrogen Peroxide 1.50%

3. Pharmaceutical Form

Hioxyl Cream is a smooth, white, non-greasy cream with virtually no odour.

4. Clinical Particulars

4.1 Therapeutic Indications

Hioxyl Cream is indicated in the treatment of leg ulcers, pressure sores, minor wounds and infections of the skin.

4.2 Posology And Method Of Administration

Route of Administration

For topical use only.

Adults, Children and the Elderly.

Hioxyl Cream is applied freely using a piece of lint or gauze. If necessary it may be covered with a dressing. The application is repeated as required.

4.3 Contraindications

There are no known contra-indications except true hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Care should be taken to avoid usage with other medicaments due to possible interaction negating the active ingredient. Care should be taken to avoid contact with dyed fabrics as this product may adversely affect dye fastness.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Hydrogen Peroxide is an oxidising agent and should not be used in conjunction with other topical agents which would react with an oxidising agent.

4.6 Pregnancy And Lactation

Hioxyl Cream is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable. Hioxyl Cream is for topical use only.

4.8 Undesirable Effects

Not applicable.

4.9 Overdose

Not applicable. Hioxyl Cream is for topical use only.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The antiseptic effect of hydrogen peroxide is a result of its ready release of oxygen when applied to tissues. The effect only lasts as long as oxygen is being released, and for solutions of hydrogen peroxide, this is of only short duration.

Hioxyl Cream is a unique formulation in which hydrogen peroxide has been stabilised in a soothing, easy to apply cream to give prolonged antiseptic action.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactic Acid B.P., White Soft Paraffin B.P., Sodium Acid Phosphate B.P., Maize Starch B.P., Cetyl Stearyl Alcohol, Sodium Cetyl Stearyl Sulphate, P.E.G. 40 Castor Oil, Purified Water B.P.

6.2 Incompatibilities

Hioxyl Cream should not be used at the same time as other topical medicaments. It is an oxidising agent and other topical agents may negate the effect of the active ingredient.

6.3 Shelf Life

18 months.

6.4 Special Precautions For Storage

Hioxyl Cream should be stored in a cool dry place avoiding extremes of temperature i.e not less than 5 degrees centigrade and not more than 30 degrees centigrade.

6.5 Nature And Contents Of Container

Hioxyl Cream is packed in low density polyethylene tubes of 25g and 100g with flush fitting cap.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Quinoderm Limited

Manchester Road

Hollinwood

OLDHAM

OL8 4PB

Lancashire

England

8. Marketing Authorisation Number(S)

PL 0291/0008

9. Date Of First Authorisation/Renewal Of The Authorisation

28/11/79

10. Date Of Revision Of The Text

February 1997

Legal category

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