It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

DDD Limited

DDD Limited

Summary of Product Characteristics last updated on medicines.ie: 13/3/2014

Dentinox Cradle Cap Treatment Shampoo

1. NAME OF THE MEDICINAL PRODUCT

Dentinox Cradle Cap Treatment Shampoo

Sodium lauryl ether sulpho-succinate 6% w/w

Sodium lauryl ether sulphate 2.7% w/w

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium lauryl ether sulpho-succinate 6.00% w/w.

Sodium lauryl ether sulphate 2.70% w/w.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Shampoo

A clear, colourless shampoo.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of infant cradle cap, and general care of infant scalp, and hair.

4.2 Posology and method of administration

Two shampoo applications of between 2-3ml. Repeat at each bath-time until the scalp is clear. Then use as necessary.

Wet the baby's head with warm water. Squeeze a little Dentinox Cradle Cap Treatment Shampoo onto your palm, and massage gently but firmly over the entire scalp. Do not be afraid of touching the soft area of the scalp (fontanelle). Avoid excess massaging and use of hot water. Rinse off and repeat application. Rinse well and gently dry.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Do not use on broken or infected skin.

4.4 Special warnings and precautions for use

For external applications only.

Keep all medicines out of the sight and reach of children.

Avoid contact with eyes.

Skin irritation may occur. To test for hypersensitivity, the shampoo should be applied to a small area and washed off after a few minutes. If the treated area shows signs of redness or inflammation within twenty-four hours, the product should not be used on the scalp. Treatment should be discontinued if there are any signs of skin reaction.

Avoid excess massaging, use of very hot water or use of other shampoos at the same time as Dentinox Cradle Cap Treatment Shampoo as these may irritate the skin. Do not try to remove the scales by picking at them as this could lead to secondary infection.

Atopic dermatitis may be exacerbated by use of surfactants such as Dentinox Cradle Cap Treatment Shampoo. Do not use if there are signs of atopic eczema such as itching, erythema, swelling/blistering or skin cracking, dryness or exfoliation.

4.5 Interaction with other medicinal products and other forms of interaction

Not applicable.

4.6 Pregnancy and lactation

Not applicable.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

The following adverse events have been reported during post-marketing (frequency unkown).

System Organ Class

General disorders and administration site conditions

Application site hypersensitivity

Application site erythema

Application site irritation

Application site inflammation

Application site alopecia

Application site dryness

4.9 Overdose

Overdosage by external application will not be a problem.

Shampoo is non-toxic if ingested.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Dentinox Cradle Cap Treatment Shampoo contains two principal cleansing surfactants:

a) Sodium lauryl ether sulphate- an anionic surfactant widely used in cosmetics and toiletries,

and

b) Sodium lauryl ether sulpho-succinate - a secondary anionic surfactant employed on account of its exceptionally mild character.

A clinical trial carried out by Huntingdon Research Centre found that the product was effective in 25 out of 26 patients treated. A 1% cetavlon placebo was used as a control.

The product is non- toxic, and has similar eye irritation potential to typical family shampoos though less than antidandruff shampoos.

5.2 Pharmacokinetic properties

Not applicable.

Dentinox Cradle Cap Treatment Shampoo has a cleansing action. The product is massaged into the scalp with a little water, then rinsed off.

5.3 Preclinical safety data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium salt of coconut imidazoline

Oleic acid diethanolamide

Sodium chloride

Dilute hydrochloric acid

Rose perfume

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

125 ml white high density polythene bottle with snap fit closure in white polypropylene.

Each container packed in a unit carton. Pack size 125 ml.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

DDD Limited

94 Rickmansworth Road

Watford

Hertfordshire WD18 7JJ

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

PA 302/1111

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 09 January 1995

Date of last renewal: 09 January 2010

10. DATE OF REVISION OF THE TEXT

January 2014

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.