Carnation Callous Caps
PRODUCT SUMMARY
1. NAME OF THE MEDICINAL PRODUCT
Carnation callous caps
Boots medicated callous treatment plasters 40% Tesco Medicated Callous Treatment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic Acid BP 40.0% w/w
3. PHARMACEUTICAL FORM
Dressings with centre ring containing Salicylic Acid Paste.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For the removal of callouses.
4.2. Posology and Method of Administration
One medicated dressing to be applied every three days.
Estimated treatment period six days.
Do not use for more than two weeks except after medical advice.
Dosage Adults and Elderly:
Treatment comprises 2 Medicated Dressings for topical application. A medicated dressing is placed over the callous and left in place for 3 days and then removed. The area is cleaned to remove any loose skin. The second medicated dressing may then be applied if the callous has not been completely removed.
Children:-
Children under 16 should seek medical advice before use.
4.3. Contra-Indications
Not to be used by diabetics. Patients with severe circulatory disorders should seek Professional Medical advice before use.
Do not use if callous or surrounding skin is inflamed or broken.
Do not use on patients hypersensitive to Salicylic Acid or to any of the components of the preparation.
4.4. Special Warnings and Special Precautions for Use
1) Discontinue use and remove dressing if excess discomfort or irritation is experienced, -or if sensitivity develops.
2) . Do not apply to normal skin
3) . Do not treat callous with any other medicated product, while using this product.
4) .If symptoms persist seek professional medical advice.
5) . Contains Arachis oil (peanut oil) and should not be applied by patients known to be allergic to Peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid using this product.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
None with other medicaments. Absorbed Salicylic Acid may theoretically interfere with assays for theophylline at low concentrations.
4.6. Pregnancy and Lactation
Safety in pregnancy and lactation has not been established. Use if considered safe after professional medical advice.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
May cause local irritation or dermatitis.
4.9. Overdose
Not applicable
5. Pharmacological Properties
5.1. Pharmacodynamic Properties
Salicylic Acid has Keratolytic properties and externally applied it produces a slow destruction of the epithelium. The epidermis desquamates making the underlying layer more accessible to debridement.
5.2. Pharmacokinetic Properties
Formulation designed to provide gradual release of Salicylic Acid to restricted area of callous. It is absorbed into the outer epidermis.
5.3. Pre-clinical Safety Data
Not applicable
6. Pharmaceutical Particulars
6.1. List of Excipients
Yellow Beeswax BP
Stabelite Resin (Partially Hydrogenated Wood Resin)
Arachis Oil BP
Softisan 378 (Vegetable Triglyceride)
E124 Ponceau 4R E110 Sunset Yellow
6.2. Incompatibilities
None known
6.3. Shelf Life
36 months
6.4. Special Precautions for Storage
Store at less than 30oC, away from direct sources of heat and humidity.
6.5. Nature and Content of Container
2 Medicated Dressings in a cardboard wallet or flow wrap bag, 15 wallets to one cardboard outer.
6.6. Instructions for Use, Handling and Disposal
No special instructions apply.
7. MARKETING AUTHORISATION HOLDER
Cuxson Gerrard & Company Limited
125 Broadwell Road
OLDBURY
West Midlands
B69 4BF
8. MARKETING AUTHORISATION NUMBER(S)
PL 00089/5006R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
06 February 1990 / 24 February 1997
10. DATE OF (PARTIAL) REVISION OF THE TEXT
December 2003