This information is intended for use by health professionals

1. Name of the medicinal product

Dentinox Cradle Cap Treatment Shampoo

2. Qualitative and quantitative composition

Sodium lauryl ether sulpho-succinate

Sodium lauryl ether sulphate

6.00 % w/w

2.70 % w/w

For full list of excipients see section 6.1

3. Pharmaceutical form

Shampoo

Colourless viscous liquid

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 or hot water. Rinse off and repeat application. Rinse well and gently dry.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients

Do not use on broken skin or infected skin.

4.4 Special warnings and precautions for use

For external application only.

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

Avoid contact with the 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 or 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 unknown).

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

Hair loss may occur as hairs caught in the cradle cap will be removed when the patch falls off. This is part of the natural history of the condition.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.

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

Pharmacotherapeutic Group: Other Dermatological preparations.

ATC Code: D11 AX.

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, which was effective in only 6 patients out of 19 treated.

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

N/A

6. Pharmaceutical particulars
6.1 List of excipients

Sodium Salt of Coconut Imidazoline, Polyoxyethylene Rapeseedamide, Sodium Chloride, Dilute Hydrochloric Acid, Rose Perfume, Purified Water.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

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

Pack size 125ml

2.7g sachet of 40gsm Craft Paper, 10gsm Polyethylene, 8 micrometer Aluminum Foil and 30gsm Surlyn. Pack size 2.7g

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

No Special requirements.

7. Marketing authorisation holder

DDD LIMITED,

94, Rickmansworth Road,

Watford,

Hertfordshire,

United Kingdom,

WD18 7JJ

8. Marketing authorisation number(s)

PL 00133/0030

9. Date of first authorisation/renewal of the authorisation

20/07/2006

10. Date of revision of the text

05/01/2018