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NUMARK BABY CREAM

Active substance(s): BENZALKONIUM CHLORIDE / CETRIMIDE / BENZALKONIUM CHLORIDE / CETRIMIDE / BENZALKONIUM CHLORIDE / CETRIMIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Neo Baby Cream,
Morrisons Baby Cream
Numark Cream
Vantage Baby Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide BP 0.2%
Benzalkonium Chloride 50% BP 0.1%

3

PHARMACEUTICAL FORM
Cream

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment and prevention of rashes caused by chafing such as napkin
rash.

4.2

Posology and method of administration
At each nappy change apply to the baby’s bottom after first washing and
drying the skin.

4.3

Contraindications
Do not use the cream if the infant is known to be sensitive to any of the ingredients.

4.4

Special warnings and precautions for use
The cream contains a derivative of lanolin which may cause local skin reactions eg.
contact dermatitis.

4.5

Interaction with other medicinal products and other forms of interaction
No interactions recorded when used as directed.

4.6

Pregnancy and lactation
Not applicable.

4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
None recorded.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The active agents are both Quaternary Ammonium compounds which are
bactericidal agents. They help reduce bacterial breakdown of urea in the urine
which is a major cause of napkin rash.

5.2

Pharmacokinetic properties
The active agents are held in solution and available for topical effect. The
cream base also contains Silicone Oil which while not declared as an active
does help form a surface barrier on the skin.

5.3

Preclinical safety data
None recorded.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Cetyl Alcohol,
Non Ionic Emulsifying Wax,
White Soft Paraffin,
Propyl Hydroxybenzoate,
Silicone Oil,
Poloxyethylene Lanolin Complex,
Perfume and Purified Water.

6.2

Incompatibilities
Quaternary Ammonium Compounds have their activity reduced by any
residual soap left on the baby’s skin.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Store below 25°C.
Do not freeze.

6.5

Nature and contents of container
50g Aluminium Tube,
125g Polypropylene Tub.

6.6

Special precautions for disposal
No special instructions required.

7

MARKETING AUTHORISATION HOLDER
Neo Laboratories Ltd.
51-53 Stert Street
Abingdon
Oxfordshire OX14 3JF
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 02019/5002R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
3 June 1987 / 23 September 1992

10

DATE OF REVISION OF THE TEXT
15/04/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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