INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
TRANS-VER-SAL (Dermal Patch)

SCHEDULING STATUS:
Schedule 0

PROPRIETARY NAME
(and dosage form):

TRANS-VER-SAL (Dermal Patch)

COMPOSITION:
Each gram contains: Salicylic acid 150 mg [15% m/m]
Preservative: Quaternium 15        0,2% m/m

PHARMACOLOGICAL CLASSIFICATION
A 13.8 Dermatological preparations. Keratolytics.

PHARMACOLOGICAL ACTION
The mode of action of salicylic acid in wart treatment appears to be due to a keratolytic action which results in mechanical removal of stratum corneum cells infected with the papilloma virus.

INDICATIONS
TRANS-VER-SALis indicated for the removal of common warts.

CONTRA-INDICATIONS
Salicylic acid should not be used in the following cases:

•	Persons with a known hypersensitivity to salicylic acid, aspirin or similar medicines.
•	Diabetics.
•	Severe circulatory disorders, except following a doctor’s recommendation.
•	If skin around the corn is infected, inflamed or broken. Do not apply to normal skin.
•	Children under the age of 2 years.
•	Not to be used on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes.

WARNINGS
Discontinue use if excessive irritation of surrounding skin appears.
Do not apply to normal skin.
FOR EXTERNAL USE ONLY.

INTERACTIONS
Concurrent use of TRANS-VER-SAL with abrasive or medicated soaps, acne preparations containing a peeling agent (benzoyl peroxide, resorcinol, sulphur, tretinoin), topical acne preparations, topical alcohol-containing preparations (such as after-shave lotions), cosmetics or soap with a strong drying effect or isotretinoin may cause an irritant or drying effect.

PREGNANCY AND LACTATION
Studies in humans have not been done. TRANS-VER-SALshould only be used during pregnancy if the potential benefit justifies the potential risk to the foetus.
Salicylic acid may be systemically absorbed. Because of the potential for serious adverse events in nursing infants, a choice must be made whether to discontinue nursing or to discontinue TRANS-VER-SAL, taking into account the importance of the medicine to the mother.

DOSAGE AND DIRECTIONS FOR USE
TRANS-VER-SAL patches are applied at night before retiring.

1.	Wash affected area. Dry area thoroughly. Gently smooth wart surface with emery file supplied.
2.	Peel patch from clear strip, leaving top blue plastic film in place and trim to wart size.

IMPORTANT –Patch must be trimmed carefully to completely cover wart, but not to come in contact with unaffected surrounding skin.

3.	Apply a drop of warm water to wart using a cotton-tip applicator, keeping surrounding skin dry.
4.	Apply medicated patch at bedtime, blue side up, sticky bottom side to wart.
5.	Secure patch in place with tape enclosed in kit.

Remove patch in morning (after at least eight hours) and discard. Repeat steps one through five every 24 hours until wart is completely removed (up to 12 weeks). Visible improvement generally occurs during the first several days of treatment. Complete removal may be expected after 3 to 12 weeks of use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following side effects have been reported but the frequencies are unknown.
•        Skin and subcutaneous tissue disorders:
Skin irritation and contact dermatitis is possible after continued use. In event of such reactions, discontinue use to allow irritation to subside.
If salicylic acid is applied to large areas of the skin acute systemic salicylic acid poisoning may occur. Localised irritation will occur if the patch is applied in contact with normal skin surrounding wart tissue.
Should you think you may have any other side-effects from the use of this product, please inform your doctor or pharmacist.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Discontinue use of this product should excessive discomfort, irritation or sensitivity develop. Treatment would be symptomatic and supportive.

IDENTIFICATION
Strips of 6 mm, 12 mm and 20 mm gel patches.

PRESENTATION
Gel patches packed into polyester-foil-polyethylene laminated pouches.
TRANS-VER-SALis available in three patch sizes:

Name	Patch Size	Patch Count	Securing Tapes
TRANS-VER-SALSmall Patch	6 mm	15	18
TRANS-VER-SALMedium Patch	12 mm	12	12
TRANS-VER-SALLarge Patch	20 mm	10	10
Each TRANS-VER-SAL kit also includes dermal tape and one emery file per carton

Each patch is sealed in a moisture resistant, polyester-foil-polyethylene laminated pouch and packed into an outer carton.

STORAGE INSTRUCTIONS
Store below 25ºC. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
38/13.8/0079

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Genop Healthcare (Pty) Ltd.
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
11 August 2006

Updated on this site: September 2009
Source: Pharmaceutical Industry
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