Dentinox Cradle Cap Treatment Shampoo

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

SODIUM LAURYL, ETHER SULFATE, ETHER SULFO, SUCCINATE

Saatavilla:

DDD Limited 94 Rickmansworth Road, Watford Herts WD18 7JJ, United Kingdom

ATC-koodi:

D11A

INN (Kansainvälinen yleisnimi):

SODIUM LAURYL ETHER SULFATE 2.7 % (W/W) SODIUM LAURYL ETHER SULFO SUCCINATE 6 % (W/W)

Lääkemuoto:

CUTANEOUS LIQUID

Koostumus:

SODIUM LAURYL ETHER SULFATE 2.7 % (W/W) SODIUM LAURYL ETHER SULFO SUCCINATE 6 % (W/W)

Prescription tyyppi:

OTC

Terapeuttinen alue:

OTHER DERMATOLOGICAL PREPARATIONS

Valtuutuksen tilan:

Suspended

Valtuutus päivämäärä:

2006-03-28

Pakkausseloste

DDD Limited
Dentinox Cradle Cap Treatment Shampoo
PACKAGE LEAFLET: INFORMATION FOR THE USER
DENTINOX CRADLE CAP TREATMENT SHAMPOO
Sodium lauryl ether sulfo-succinate, Sodium lauryl ether sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
If you need more information or advice speak to your health visitor,
pharmacist or doctor.
IN THIS LEAFLET:
1. What Dentinox Cradle Cap Treatment Shampoo is and what it is used
for
2. Before you use Dentinox Cradle Cap Treatment Shampoo
3. How to use Dentinox Cradle Cap Treatment Shampoo
4. Possible side effects
5. How to store Dentinox Cradle Cap Treatment Shampoo
6. Further information
7. About cradle cap
1.
WHAT DENTINOX CRADLE CAP TREATMENT SHAMPOO IS AND WHAT IT IS USED FOR
Dentinox Cradle Cap Treatment Shampoo contains the active ingredients
sodium lauryl ether sulfo-
succinate and sodium lauryl ether sulfate, which belong to a group of
medicines called cleansing
surfactants. These cleansers have been shown to be effective in the
treatment of cradle cap.
Dentinox Cradle Cap Treatment Shampoo is for the treatment of infant
cradle cap, and general care of
infant scalpand hair.
This shampoo is suitable to use from birth onwards.
2.
BEFORE YOU USE DENTINOX CRADLE CAP TREATMENT SHAMPOO
_ _
You should not use Dentinox Cradle Cap Treatment Shampoo:
• If your baby is allergic (hypersensitive) to sodium lauryl ether
sulfo-succinate, sodium lauryl ether
sulfate, or any other ingredients of Dentinox Cradle Cap Treatment
Shampoo (see list of ingredients
in Section 6).
• If the skin on the scalp is broken.
• If there are signs of scalp infection (redness, blistering,
oozing, warmth).
TAKE SPECIAL CARE WITH DENTINOX CRADLE CAP TREATMENT SHAMPOO.
• Avoid contact with the eyes.
• Do not use if your baby has any signs of eczema on the scalp such
as redness, swelling, blistering,
dryness or cracking of the skin.
• Test on a small area of the infant’s skin the day before you
intend to use the shampoo

Valmisteyhteenveto

Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dentinox Cradle Cap Treatment Shampoo
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.
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 and use of 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 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
itchin