Boots Cradle Cap cream from Birth

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Almond oil; Wool fat

Available from:

The Boots Company Plc

ATC code:

n/a

INN (International Name):

Almond oil; Wool fat

Dosage:

50mg/1gram ; 10mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 19020505; GTIN: 5000167081398

Patient Information leaflet

BOOTS CRADLE CAP CREAM
Almond Oil, Lanolin
Prevents Soreness
Softens and moistens skin
25 g e
READ ALL OF THIS CARTON FOR FULL INSTRUCTIONS.
WHAT THIS MEDICINE IS FOR
A cream for the treatment of cradle cap. Moistens the skin and
prevents soreness.
BEFORE YOU USE THIS MEDICINE DO NOT USE:
•
IF YOUR CHILD IS ALLERGIC to any of the ingredients
Cetyl alcohol may cause skin reactions (e.g. contact dermatitis).
ADULTS: Do not use yourself if you are allergic to the ingredients, or
if you are a woman who
is pregnant or breastfeeding unless your doctor tells you to.
HOW TO USE THIS MEDICINE
Check the tube seal is not broken before first use. If it is, do not
use the cream. Pierce tube
seal with end of cap. Apply to the skin only.
DIRECTIONS: Gently massage a little cream onto the scalp where it is
needed.
Use the cream 2 or 3 times a day, if you need to.
It is also recommended that the child’s head is washed regularly
with a mild shampoo.
If symptoms do not go away talk to your pharmacist or doctor.
IF ANYONE ACCIDENTALLY SWALLOWS SOME: Talk to a pharmacist or doctor.
POSSIBLE SIDE EFFECTS
Most people will not have problems.
IF YOU GET THESE SIDE EFFECTS STOP USING THE CREAM AND SEE A DOCTOR:
•
Skin rash
IF YOU NOTICE ANY SIDE EFFECT NOT LISTED HERE, PLEASE TELL YOUR
PHARMACIST OR DOCTOR.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Use by the date on the end flap of the carton.
ACTIVE INGREDIENTS
This cream contains Almond Oil 5% w/w, Anhydrous Lanolin 1% w/w.
Also contains: purified water, cetyl alcohol, white soft paraffin,
cetomacrogol 1000, benzyl
alcohol, sorbitan sesquioleate, sodium citrate, citric acid.
PL 00014/0368
Text prepared 6/10
Manufactured by the Marketing Authorisation holder The Boots Company
PLC Nottingham
NG2 3AA
If you need more advice ask your pharmacist.
BTC56779 vE 20/10/10

Summary of Product characteristics

OBJECT 1
BOOTS CRADLE CAP CREAM
Summary of Product Characteristics Updated 04-May-2011 | THE BOOTS
COMPANY PLC
1. Name of the medicinal product
Boots Cradle Cap Cream
2. Qualitative and quantitative composition
Active ingredients
%w/w
Anhydrous lanolin
1.0
Almond oil BP'88
5.0
3. Pharmaceutical form
Cream
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of cradle cap.
For topical application to the scalp.
4.2 Posology and method of administration
Apply to the affected area two or three times a day as required.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
For external use only.
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of
interaction
There are no clinically significant interactions known.
4.6 Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been
established but is not considered to
constitute a hazard during these periods.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Adverse reactions are unlikely, but may occasionally cause an allergic
skin reaction, in which case use of
the product should be discontinued.
4.9 Overdose
This product has low toxicity. If accidental ingestion occurs,
conservative treatment only is required.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Lanolin and almond oil help to moisturise the skin and prevent
soreness.
5.2 Pharmacokinetic properties
Lanolin is not by itself readily absorbed but when mixed with a
suitable vegetable oil, in this case almond
oil, it gives emollient creams which penetrate the skin.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are
additional to that already included.
6. Pharmaceutical particulars
6.1 List of excipients
White soft paraffin
Cetomacrogol 1000
Arlacel 83
Cetyl alcohol
Benzyl alcohol
Anhydrous citric acid
Sodium citrate
Purified water
6.2 Incom