Label: SALYNTRA- salicylic acid gel
- NDC Code(s): 83592-125-60
- Packager: True Marker Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 25, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- PURPOSE
- Uses
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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.
- KEEP OUT OF REACH OF CHILDREN
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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
- Inactive Ingredients
- Questions or comments? call 877-887-9879
- Product label
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INGREDIENTS AND APPEARANCE
SALYNTRA
salicylic acid gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:83592-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 6 g in 100 g Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83592-125-60 60 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2024 Labeler - True Marker Pharmaceuticals, Inc. (119046582) Registrant - True Marker Pharmaceuticals, Inc. (119046582)
