Antiseptic Foot Balm
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Antiseptic Foot Balm
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ingredient %w/w
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Relief of foot discomfort. Cools, soothes painful bunions and sore tender spots. Helps heal blister and cracked skin. Helps relieve itching chilblains and tenderness caused by excessive perspiration.
4.2 Posology and method of administration
Route of Administration: Topical
Smooth the balm over the feet and between the toes. For best results bathe and dry feet first.
Recommended Doses: Use night and morning
No distinction is made between the different categories of patient.
4.3 Contraindications
Not to be used by diabetics, except with a doctor’s permission.
4.4 Special warnings and precautions for use
Not to be used by diabetics, except with a doctor’s permission. Keep out of reach of children. For external use only.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Pregnancy and lactation
No known restrictions.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
None stated.
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
|
ACTIVE INGREDIENT |
PHARMACOLOGICAL PARTICULARS |
|
Halquinol |
Antimicrobial |
|
Menthol |
Cooling and mild local anaesthetic |
|
Methyl Salicylate |
Counter irritant, mild analgesic |
5.2 Pharmacokinetic properties
Not applicable for a topical dosage form
5.3 Preclinical safety data
No other information relevant to the prescriber other than that already stated in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Stearic Acid Emulsifying Wax Triethanolamine Sorbic Acid
Methyl P-Hydroxybenzoate Propyl P-Hydroxybenzoate
1,2 - Propylene Glycol Demineralised Water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months unopened.
Special precautions for storage
6.4
Store at or below 25 °C.
6.5 Nature and contents of container
Epoxy lined aluminium tube with seal and plastic cap containing 25g of product.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
AYRTON SAUNDERS LIMITED NORTH WAY
WALWORTH INDUSTRAIL ESTATE
ANDOVER
SP10 5AZ
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0156
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29th August 1984 / 26th January 1995
10 DATE OF REVISION OF THE TEXT
08/03/2008