HYDROMOL CREAM
Active substance: SODIUM PYRROLIDONE CARBOXYLATE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
HYDROMOL CREAM
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Pyrrolidone Carboxylate 2.5%. Excipients: Cetomacrogol emulsifying wax contains cetostearyl alcohol. For full list of excipients see Section 6.1.
3.
PHARMACEUTICAL FORM Hydromol Cream is a soft, white, oil-in-water cream which can be massaged easily into the skin.
4. 4.1.
CLINICAL PARTICULARS Therapeutic Indications Any condition in which "dry skin" is a feature, including all forms of dermatitis / eczema and all degrees of icthyosis and senile pruritus.
4.2.
Posology and Method of Administration Route of administration For topical use only. Adults, Children and the Elderly: Apply liberally to the affected area and massage well into the skin. Hydromol Cream may be used as often as required. Hydromol Cream is especially beneficial when used immediately after washing or bathing, when the resultant warmth of the skin enhances absorption.
4.3.
Contra-Indications
There are no contraindications except true hypersensitivity to any of the ingredients.
4.4.
Special Warnings and Special Precautions for Use The formulation is not designed for use as a diluent.
4.5.
Interactions with other Medicinal Products and other Forms of Interaction None known.
4.6.
Pregnancy and Lactation Hydromol Cream is not contra-indicated in pregnancy or lactation.
4.7.
Effects on Ability to Drive and Use Machines Not applicable.
4.8
Undesirable effects Rarely a non serious allergic type reaction may be experienced, e.g. rash.
4.9.
Overdose Not applicable. Hydromol Cream is for topical use only.
5. 5.1.
PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties The combination of oils used in Hydromol Cream helps to lubricate and hydrate the skin. Moisture loss from the stratum corneum is reduced by the formation of an occlusive film by liquid paraffin on the surface of the skin. Isopropyl myristate, a fatty acid ester, is easily absorbed into the skin and helps to improve skin softness.
5.2.
Pharmacokinetic Properties Sodium pyrrolidone carboxylate positively aids the hydration of the skin.
5.3.
Pre-clinical Safety Data None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients
Liquid Paraffin Isopropyl Myristate Sodium Lactate Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol) Myristyl Myristate Cetomacrogol 1000 Hydroxybenzoates (Parabens) Phenoxyethanol Purified Water 6.2. Incompatibilities Not applicable, Hydromol Cream is for topical use only.
6.3.
Shelf-Life 2 years.
6.4.
Special Precautions for Storage Hydromol Cream should be stored in a dry place avoiding extremes of temperature i.e. not less than 5C and not more than 30C.
6.5
Nature and contents of container
Hydromol Cream is packed in low density polyethylene tubes of 10 g, 50 g and 100 g with a flush fitting cap. It is also available in polypropylene tubs containing 500 g with pump dispenser. Not all pack sizes may be marketed. 6.6. Instruction for Use, Handling and Disposal
No special instructions.
7.
MARKETING AUTHORISATION HOLDER Alliance Pharmaceuticals Ltd Avonbridge House Bath Road Chippenham Wiltshire SN15 2BB United Kingdom
8.
MARKETING AUTHORISATION NUMBER(S) PL 16853/0089
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/05/2008
10
DATE OF REVISION OF THE TEXT
20/03/2009
1
NAME OF THE MEDICINAL PRODUCT
HYDROMOL CREAM
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Pyrrolidone Carboxylate 2.5%. Excipients: Cetomacrogol emulsifying wax contains cetostearyl alcohol. For full list of excipients see Section 6.1.
3.
PHARMACEUTICAL FORM Hydromol Cream is a soft, white, oil-in-water cream which can be massaged easily into the skin.
4. 4.1.
CLINICAL PARTICULARS Therapeutic Indications Any condition in which "dry skin" is a feature, including all forms of dermatitis / eczema and all degrees of icthyosis and senile pruritus.
4.2.
Posology and Method of Administration Route of administration For topical use only. Adults, Children and the Elderly: Apply liberally to the affected area and massage well into the skin. Hydromol Cream may be used as often as required. Hydromol Cream is especially beneficial when used immediately after washing or bathing, when the resultant warmth of the skin enhances absorption.
4.3.
Contra-Indications
There are no contraindications except true hypersensitivity to any of the ingredients.
4.4.
Special Warnings and Special Precautions for Use The formulation is not designed for use as a diluent.
4.5.
Interactions with other Medicinal Products and other Forms of Interaction None known.
4.6.
Pregnancy and Lactation Hydromol Cream is not contra-indicated in pregnancy or lactation.
4.7.
Effects on Ability to Drive and Use Machines Not applicable.
4.8
Undesirable effects Rarely a non serious allergic type reaction may be experienced, e.g. rash.
4.9.
Overdose Not applicable. Hydromol Cream is for topical use only.
5. 5.1.
PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties The combination of oils used in Hydromol Cream helps to lubricate and hydrate the skin. Moisture loss from the stratum corneum is reduced by the formation of an occlusive film by liquid paraffin on the surface of the skin. Isopropyl myristate, a fatty acid ester, is easily absorbed into the skin and helps to improve skin softness.
5.2.
Pharmacokinetic Properties Sodium pyrrolidone carboxylate positively aids the hydration of the skin.
5.3.
Pre-clinical Safety Data None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients
Liquid Paraffin Isopropyl Myristate Sodium Lactate Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol) Myristyl Myristate Cetomacrogol 1000 Hydroxybenzoates (Parabens) Phenoxyethanol Purified Water 6.2. Incompatibilities Not applicable, Hydromol Cream is for topical use only.
6.3.
Shelf-Life 2 years.
6.4.
Special Precautions for Storage Hydromol Cream should be stored in a dry place avoiding extremes of temperature i.e. not less than 5C and not more than 30C.
6.5
Nature and contents of container
Hydromol Cream is packed in low density polyethylene tubes of 10 g, 50 g and 100 g with a flush fitting cap. It is also available in polypropylene tubs containing 500 g with pump dispenser. Not all pack sizes may be marketed. 6.6. Instruction for Use, Handling and Disposal
No special instructions.
7.
MARKETING AUTHORISATION HOLDER Alliance Pharmaceuticals Ltd Avonbridge House Bath Road Chippenham Wiltshire SN15 2BB United Kingdom
8.
MARKETING AUTHORISATION NUMBER(S) PL 16853/0089
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/05/2008
10
DATE OF REVISION OF THE TEXT
20/03/2009
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.
