Savlon Antiseptic Cream Cetrimide 0.5% w/wChlorhexidine Digluconate 0.1% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cetrimide; Chlorhexidine gluconate

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC code:

D08AJ; D08AJ04

INN (International Name):

Cetrimide; Chlorhexidine gluconate

Dosage:

0.5/0.1 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Quaternary ammonium compounds; cetrimide

Authorization status:

Marketed

Authorization date:

1991-06-26

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Savlon Antiseptic Cream
Cetrimide 0.5% w/w
Chlorhexidine Digluconate 0.1% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Cetrimide 0.50% w/w
Chlorhexidine digluconate 0.10% w/w
Excipients:
Cetostearyl alcohol 10.00% w/w
Methyl parahydroxybenzoate (E218) 0.01% w/w
Propyl parahydroxybenzoate (E216) 0.01% w/w
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream.
Smooth, white, homogenous cream with an antiseptic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For prevention and management of superficial infections in skin tissue
including wounds and minor burns.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use.
Apply the cream over the affected area after cleansing.
4.3 CONTRAINDICATIONS
Hypersensitivity to chlorhexidine digluconate, cetrimide or to any of
the excipient listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Avoid contact with the eyes, ears, mouth or other mucosa.
If accidentally splashed into the eye, the open eye should be
irrigated for at least 10 minutes.
If symptoms persist or condition worsens, discontinue use and consult
a physician.
The product is incompatible with anionic substances (e.g. soap).
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