FDA Label for Salyntra

View Indications, Usage & Precautions

Salyntra Product Label

The following document was submitted to the FDA by the labeler of this product True Marker Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



salicylic acid 6%


Uses



For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with
psoriasis or thickened skin of palms and soles, corns and calluses.


Warnings



For external use only. Avoid contact with eyes an other mucous membranes. May cause mild irritation. If excessive irritation or sensitivity occurs, discontinue use and consult with your physician.

Do not use on children under 2 years of age. Read package insert carefully.

Flammable. Keep away from heat and open flame. Keep this and all medications out of reach of children.


Directions



Apply SALYNTRA GEL thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated (soaked in water) for at lest five minutes prior to application. The medication is washed off in the morning. In those areas where occlusion is difficult or impossible, application is washed off in the morning. In those areas where occlusion is difficult or impossible, application may be made more frequently. Once clearing is apparent, the occasional use of SALYNTRA GEL will usually maintain the remission. Unless hands are being treated, hands should be rinsed thoroughly after application.


Other Information



Store at controlled room temperature 59 to 86 F (15 to 30 C)


Inactive Ingredients



hydroxypropyl cellulose, propylene glycol


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Product Label




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