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DDD Limited
94 Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ
Telephone: +44 1923 22 9251
Fax: +44 1923 22 0728
WWW: http://www.dddgroup.co.uk
Medical Information Direct Line: +44 1923 22 9251
Medical Information Direct Line: +44 7977989686
Medical Information e-mail: info@dentinox.co.uk
Customer Care direct line: +44 1923 22 9251
Medical Information Fax: +44 1923 220 728

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Summary of Product Characteristics last updated on the eMC: 17/09/2009
SPC DENTINOX CRADLE CAP TREATMENT SHAMPOO


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1. NAME OF THE MEDICINAL PRODUCT

DENTINOX CRADLE CAP TREATMENT SHAMPOO


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium lauryl ether sulpho-succinate 6.00 % w/w

Sodium lauryl ether sulphate 2.70 % w/w

For full list of excipients see section 6.1


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3. PHARMACEUTICAL FORM

Shampoo

Colourless viscous liquid


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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


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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 ). Rinse off and repeat application. Rinse well and dry.


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4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients

Avoid contact with the eyes.


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4.4 Special warnings and precautions for use

For external application only.

Keep all medicines out of the reach of children.


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4.5 Interaction with other medicinal products and other forms of interaction

Not applicable.


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4.6 Pregnancy and lactation

Not applicable.


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4.7 Effects on ability to drive and use machines

Not applicable.


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4.8 Undesirable effects

There have been very rare reports of erythema and skin irritation


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4.9 Overdose

Overdosage by external application will not be a problem.

Shampoo is non-toxic if ingested.


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5. PHARMACOLOGICAL PROPERTIES

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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 shampoo's though less than anti-dandruff shampoos.


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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.


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5.3 Preclinical safety data

N/A


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Sodium Salt of Coconut Imidazoline, Oleic Acid Diethanolamide, Sodium Chloride,

Rose Perfume, Purified Water.


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6.2 Incompatibilities

None known.


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6.3 Shelf life

3 years


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6.4 Special precautions for storage

Do not store above 25°C


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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


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6.6 Special precautions for disposal and other handling

Special precautions for disposal


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7. MARKETING AUTHORISATION HOLDER

DDD LIMITED,

94, Rickmansworth Road, Watford, Hertfordshire, United Kingdom, WDI 7JJ


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8. MARKETING AUTHORISATION NUMBER(S)

PL 0133/0030


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of last renewal 20 July 2006


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10. DATE OF REVISION OF THE TEXT

20 July 2006



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/22136/SPC/