CETOMACROGOL CREAM BP 1988 FORMULA A.
Active substance: MACROGOL CETOSTEARYL ETHER 22
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Cetomacrogol Cream BP 1988 Formula A
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Macrogol Cetostearyl Ether 22 BP 1.8% w/w
3
PHARMACEUTICAL FORM
Cream.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For external application for use as an emollient, and for use as a diluent in medicinal external preparations.
4.2
Posology and method of administration Topical Recommended dose and dosage schedule To be used as prescribed by a registered medical practitioner or counter prescribed by a registered pharmacist. The product is suitable for use by adults, children and the elderly. Dosage: as prescribed by the medical practitioner or pharmacist.
4.3
Contraindications Sensitivity to chlorocresol.
4.4
Special warnings and precautions for use For external use only. Keep all medicines away from children.
Store below 25C. Do not allow to freeze. The diluted cream should be used within 2 weeks of preparation.
4.5
Interaction with other medicinal products and other forms of interaction None known.
4.6
Fertility, pregnancy and lactation No special precautions regarding this vehicle.
4.7
Effects on ability to drive and use machines None known.
4.8
Undesirable effects None known.
4.9
Overdose Not applicable.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties The product has an emollient effect.
5.2
Pharmacokinetic properties Not applicable.
5.3
Preclinical safety data None.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Cetostearyl alcohol BP, chlorocresol BP, liquid paraffin BP, paraffin white soft BP, water purified BP.
6.2
Incompatibilities Macrogol cetostearyl ether is incompatible with phenols and reduces the antibacterial activity of quaternary ammonium compounds.
6.3
Shelf life 500g: 36 months unopened.
6.4
Special precautions for storage Store below 25C. Do not allow to freeze.
6.5
Nature and contents of container 500g: polypropylene jar and lid.
6.6
Special precautions for disposal None.
7
MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd. Linthwaite Laboratories Huddersfield HD7 5QH
8
MARKETING AUTHORISATION NUMBER(S)
PL 00240/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31.05.74 / Last renewed 25.11.98
10
DATE OF REVISION OF THE TEXT
18th February 2002
Cetomacrogol Cream BP 1988 Formula A
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Macrogol Cetostearyl Ether 22 BP 1.8% w/w
3
PHARMACEUTICAL FORM
Cream.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For external application for use as an emollient, and for use as a diluent in medicinal external preparations.
4.2
Posology and method of administration Topical Recommended dose and dosage schedule To be used as prescribed by a registered medical practitioner or counter prescribed by a registered pharmacist. The product is suitable for use by adults, children and the elderly. Dosage: as prescribed by the medical practitioner or pharmacist.
4.3
Contraindications Sensitivity to chlorocresol.
4.4
Special warnings and precautions for use For external use only. Keep all medicines away from children.
Store below 25C. Do not allow to freeze. The diluted cream should be used within 2 weeks of preparation.
4.5
Interaction with other medicinal products and other forms of interaction None known.
4.6
Fertility, pregnancy and lactation No special precautions regarding this vehicle.
4.7
Effects on ability to drive and use machines None known.
4.8
Undesirable effects None known.
4.9
Overdose Not applicable.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties The product has an emollient effect.
5.2
Pharmacokinetic properties Not applicable.
5.3
Preclinical safety data None.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Cetostearyl alcohol BP, chlorocresol BP, liquid paraffin BP, paraffin white soft BP, water purified BP.
6.2
Incompatibilities Macrogol cetostearyl ether is incompatible with phenols and reduces the antibacterial activity of quaternary ammonium compounds.
6.3
Shelf life 500g: 36 months unopened.
6.4
Special precautions for storage Store below 25C. Do not allow to freeze.
6.5
Nature and contents of container 500g: polypropylene jar and lid.
6.6
Special precautions for disposal None.
7
MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd. Linthwaite Laboratories Huddersfield HD7 5QH
8
MARKETING AUTHORISATION NUMBER(S)
PL 00240/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31.05.74 / Last renewed 25.11.98
10
DATE OF REVISION OF THE TEXT
18th February 2002
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
