Chilblain Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chilblain Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl Nicotinate 1.00 % W/W For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Rubificient Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of pain associated with chilblains.
4.2 Posology and method of administration
For Adults, Elderly and Children.
Gently bathe affected parts in water. Dry carefully. Apply cream sparingly morning and night and more frequently if required
4.3 Contraindications
Hypersensitivity to the product.
4.4 Special warnings and precautions for use
If symptoms deteriorate or do not improve within 5 days a physician should be consulted.
Caution is advised in diabetic patients and those with poor circulation.
For external use only.
Keep out of the reach and sight of children.
Wash hands thoroughly after use and avoid touching sensitive areas of the body.
If you have sensitive skin, apply cream to a small area of skin to test whether you are allergic to the product before fully applying it.
4.5 Interaction with other medicinal products and other forms of interaction
Not known.
4.6 Fertility, Pregnancy and lactation
As with all medicines avoid in early pregnancy and lactation.
4.7 Effects on ability to drive and use machines
Not applicable, none-reported.
4.8 Undesirable effects
Temporary reddening of the skin may occur where applied.
4.9 Overdose
In the unlikely case of accidental ingestion treat symptomatically.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Methyl Nicotinate is a “vasodilator” and is used in concentrations of 1% in ointments and creams for topical application as a rubificient for the relief of pam in chilblains.
5.2 Pharmacokinetic properties
Not relevant.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sebase, Emulsifying wax, Liquid paraffin, Euxyl Kl00, Water
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25 °C and do not freeze.
6.5 Nature and contents of container
15g printed collapsible aluminium tube.
Special precautions for disposal
6.6
No special requirements, but always wash hands after using product
7 MARKETING AUTHORISATION HOLDER
Optima Consumer Health Ltd Concept house,
Brackenbeck Road,
Bradford,
BD7 2LW,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 40575/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/05/2008
10 DATE OF REVISION OF THE TEXT
30/07/2012