SUMMARY OF PRODUCT CHARACTERISTICS

1.    NAME OF THE MEDICINAL PRODUCT

OXY On-the-Spot

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains benzoyl peroxide 2.5% w/w in a cream base.

For excipients, see 6.1

3.    PHARMACEUTICAL FORM

Cream for topical administration.

Smooth, white cream.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

OXY On-the-Spot is indicated for the treatment of spots and pimples on the face.

4.2.    Posology and Method of Administration

Adults and children over 6 years of age (including the elderly):

Wash the face, rinse and then dry with a soft, clean towel. Using a fingertip, apply the cream once a day to the spots. Massage gently until the cream has vanished. Wash hands after use.

With very fair or sensitive skin apply cautiously for the first few days to avoid redness and peeling.

Not recommended for use on children under 6 years of age.

Contra-Indications

Hypersensitivity to benzoyl peroxide or any of the other ingredients.

4.4. Special warnings and precautions for use

Avoid contact with the eyes, lips and mouth.

People with a known intolerance to benzoyl peroxide should not use OXY On-the-spot; if you are unsure or have not used this product before, rub in OXY On-the-spot to a small area of the lower arm above the wrist at least 48 hours before use. If swelling or itching occurs with severe redness do not use OXY On-the-spot.

Mild burning or tingling may be felt when OXY On-the-spot is applied. Mild to moderate redness and peeling sometimes arise with continued use. This indicates that OXY On-the-spot is working. If the reaction is excessive, decrease the quantity and frequency of application and if a reaction persists, seek medical advice

Do not use OXY On-the-spot continuously for more than one month without medical advice.

Avoid prolonged or excessive exposure to sunlight/UV light.

May bleach coloured fabrics.

4.5. Interactions with other Medicinal Products and other Forms of Interaction

None known.

4.6. Pregnancy and Lactation

Use during pregnancy and lactation is not contraindicated. However, as with all medicines in pregnancy caution should be exercised.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8.    Undesirable effects

In normal use a mild burning or tingling sensation may be felt when Oxy on the Spot is applied and a mild to moderate reddening and peeling of the skin may sometimes arise with continued use. Excessive irritation or an allergic reaction may occasionally occur in certain individuals. Face oedema or swelling, skin burn with or without blistering, itching, pain, change in skin pigmentation and photosensitisation may occur.

4.9.    Overdose

Over-use is likely to cause excessive localised redness and peeling due to the drying action of benzoyl peroxide. Medical advice should be sought if this does not subside on withdrawal of the product.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Benzoyl peroxide has keratolytic activity coupled with antibacterial activity against Propionibacterium acnes, the organism implicated in acne vulgaris.

Pharmacotherapeutic group: Dermatologicals - Anti-acne preparations for topical use.

ATC Code : D10A E01.

5.2. Pharmacokinetic Properties

Benzoyl peroxide absorbed through the skin is mostly metabolised to benzoic acid which is then rapidly excreted in the urine.

5.3. Pre-clinical Safety Data

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

6.1.    List of Excipients

Isopropyl palmitate, polyethylene glycol (1000) monostearate, glyceryl monostearate, propylene glycol, stearic acid, zinc stearate and water.

6.2.    Incompatibilities

None known.

6.3    Shelf life

18 months.

6.4.    Special Precautions for Storage

Do not store above 25°C.

6.5.    Nature and Content of Container

20 g aluminium tube with an internal 6 pm phenolic resin lacquer.

6.6.    Instructions for Use, Handling and Disposal

May bleach coloured fabrics.

7.    MARKETING AUTHORISATION HOLDER

The Mentholatum Company Limited 1 Redwood Avenue Peel Park Campus

East Kilbride G745PE United Kingdom

8.    MARKETING AUTHORISATION NUMBER

PL 00189/0032

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

1 August 2005

10 DATE OF REVISION OF THE TEXT

02/05/2012