INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo AROLA ROSE BALM

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

AROLA ROSE BALM

COMPOSITION:
Per 50 gram cream:
Allantoin         1,0g
Zinc Oxide         2,5g
Dimethicone         2,5g
Bismuth Subnitrate         0,25g
Incorporated in a pleasant rose-perfumed emollient base.
Preserved with methyl hydroxybenzoate         0,15% m/m

PHARMACOLOGICAL CLASSIFICATION:
13.5 Emollients and protectives.

PHARMACOLOGICAL ACTION:
Allantoin acts as a healing agent, stimulating healthy tissue formation. Zinc Oxide has a soothing and protective action. Dimethicone is water repellent and protects the skin against water-soluble irritants. Bismuth subnitrate is an astringent.

INDICATIONS:
Arola Rose Balm has soothing, healing and protective qualities. It is recommended for the prevention and treatment of napkin rash, cracked nipples and bedsores, and for episiotomy care.

CONTRA-INDICATIONS:
Arola Rose Balm is not intended for use on open skin wounds.

WARNINGS:
For external use only.

DOSAGE AND DIRECTIONS FOR USE:
Napkin rash: apply after each napkin change and after bathing the baby. Nipple care: apply the cream three to four times a day, especially after feeding. During the ante-natal period the nipples should be massaged with the cream twice a day. Bedsores: thinly smear the cream on pressure areas twice a day.
Episiotomy care: use as directed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
None.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None

IDENTIFICATION:
Viscous off-white cream with a rose fragrance.

PRESENTATION:
Plastic jar containing 50 grams cream.

STORAGE INSTRUCTIONS:
Store in a cool place under 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
G/13.5/11.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmaceutical Enterprises (Pty) Ltd
Howard Studios, Howard Drive, Pinelands, 7405.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1993

Updated on this site: November 2001

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