Summary of Product Characteristics last updated on medicines.ie: 13/3/2014
Dentinox Cradle Cap Treatment Shampoo
Dentinox Cradle Cap Treatment Shampoo
Sodium lauryl ether sulpho-succinate 6% w/w
Sodium lauryl ether sulphate 2.7% w/w
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.
A clear, colourless shampoo.
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.
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
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
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
Overdosage by external application will not be a problem.
Shampoo is non-toxic if ingested.
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,
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
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
6.1 List of excipients
Sodium salt of coconut imidazoline
Oleic acid diethanolamide
Dilute hydrochloric acid
6.3 Shelf life
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.
94 Rickmansworth Road
Hertfordshire WD18 7JJ
Date of first authorisation: 09 January 1995
Date of last renewal: 09 January 2010