Salitop Cream

For Dermatologic Use

Salitop™ is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris and psoriasis (including body, scalp, palms and soles).

For Podiatric Use

Salitop™ is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.

Salitop™ should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salitop™ should not be used on children under 12 years of age.

For external use only. Avoid contact with eyes and other mucous membranes.

Pregnancy (Category C)

Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salitop™ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salitop™, a decision should be make whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be on the chest area to avoid the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available concerning potential carcinogenic or reproductive effects of Salitop™. It has been shown to lack mutagenic potential in the Ames Salmonella test.

DRUG INTERACTIONS

The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salitop™ is not known.

The following alterations of laboratory tests have been reported during salicylate therapy:

The preferable method of use is to apply Salitop™ thoroughly to the affected area and cover the area at night, after washing and before retiring. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed, a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salitop™ will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. (see WARNINGS). Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salitop™ will not necessarily increase it's therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

Salitop™ Cream is available in 400 gram oval-shaped container, (NDC 51991-476-46).

Salitop™ Lotion is available in 14 fl. oz. (414 mL) bottles, (NDC 51991-477-47).

Store at 25° C (77° F); excursions permitted to 15° – 30° C (59° – 86° F). See USP Controlled Room Temperature.

Protect from freezing.

Dispense in original containers.

WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

IN-47646
Rev. 2/09

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Manufactured by:
Groupe Parima, Inc.
Montreal, Qc H4S 1X6 Canada

Breckenridge
Pharmaceutical, Inc.

NDC 51991-476-46

SALITOP™
CREAM
(6% Salicylic Acid)

WARNING:
FOR DERMATOLOGICAL USE ONLY
NOT FOR:

• OPHTHALMIC USE
• ORAL USE
• INTRAVAGINAL USE

Rx Only

Net Wt. 400 g