KAMILLOSAN CHAMOMILE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHAMOMILE

Available from:

Chefaro Ireland DAC

ATC code:

D04AX

INN (International Name):

CHAMOMILE

Dosage:

10.5 %w/w

Pharmaceutical form:

Ointment

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other antipruritics

Authorization status:

Marketed

Authorization date:

2000-02-18

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kamillosan Chamomile Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tube of Kamillosan Soothing Ointment contains 10.5% extracts of
chamomile (_chamomilla nobilis_ flowers)
standardised to give 0.01% L-
-bisabolol active ingredient.
Excipients: Contains wool fat 28% w/w, Nipasept Sodium 0.1% w/w
(containing Methyl parahydroxybenzoate E218,
Ethyl parahydroxybenzoate E214 and Propyl parahydroxybenzoate E216)
Contains Emulsifying wax BP (containing cetostearyl alcohol 90%w/w and
10%w/w Sodium laurilsulfate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Light brown ointment with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prophylaxis and treatment of uncomplicated inflammation of the
skin including sore nipples, nappy chafe,
nappy rash and chapped hands.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Kamillosan Soothing Ointment is for topical application as follows:
Sore nipples in nursing mothers: after breast feeding. The nipple area
should be cleansed of ointment prior to breast
feeding.
Nappy chafe and nappy rash: at change of nappy.
Other conditions: twice daily as necessary.
4.3 CONTRAINDICATIONS
Previous hyper-sensitivity to active ingredients or excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care should be taken when applying Kamillosan Soothing ointment in
those with known sensitivity to the plants of the
Compositae family.
If symptoms persist for more than 2 weeks the patient should consult
their doctor.
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