Medicaid Antiseptic Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medicaid Antiseptic Cream Richmond Antiseptic Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide B.P 0.50% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A Water-in-Oil Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of nappy rash, chapped hands, sunburn, chafing, minor burns, cuts and abrasions.
4.2 Posology and method of administration
No restrictions by age or gender.
Apply liberally to the affected area. Repeat as necessary.
Nappy rash: after normal nappy changing routine, dry baby’s skin without rubbing, apply cream.
First aid use: wash affected area gently, pat dry, and apply to soothe and help prevention infection.
Contraindications
4.3
Hypersensitivity to the active, and any of the listed ingredients.
4.4 Special warnings and precautions for use
Keep all medicines away from children.
If symptoms persist, stop using and consult your doctor
4.5 Interaction with other medicinal products and other forms of interaction
None
4.6 Fertility, Pregnancy and lactation
Although there are no adverse reports for this product in pregnant and lactating mothers, as with all medicines, care should be exercised when administering the product to pregnant or lactating women.
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
Skin irritation has been reported.
Hypersensitivity reactions may develop in certain individuals presenting as a
localised contact dermatitis
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
It is unlikely that systemic toxicity will result from the ingestion of Medicaid Antiseptic Cream, although it may give rise to gastrointestinal irritation.
Treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiseptic cream ATC code: D08AJ04
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White Soft Paraffin
B.P.
B.P.
B.P.
H.S.E
H.S.E
B.P.
H.S.E
H.S.E
B.P.C
Lanolin (Anhydrous) Cetostearyl Alcohol
Glyceryl Monostearate Myristyl Alcohol
Cetomacrogol 1000 Nipasept
Perfume compound Deionized Water
6.2 Incompatibilities
None
6.3 Shelf life
60 months.
6.4 Special precautions for storage
None
6.5 Nature and contents of container
White low density polythene tube, lacquered and fitted with a white full skirted polypropylene cap.
Contents: 5, 10, 15, 25, 30, 50, 60, 100 gm
6.6 Special precautions for disposal
No special instructions required.
MARKETING AUTHORISATION HOLDER
7
Biobos Ltd 33 Heather Drive Thatcham Berkshire RG18 4BU
8 MARKETING AUTHORISATION NUMBER(S)
PL 43217/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/07/1988 / 09/08/2010
10 DATE OF REVISION OF THE TEXT
13/10/2016