SALYNTRA- salicylic acid gel 
True Marker Pharmaceuticals, Inc.

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.

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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

Questions or comments? call 877-887-9879

Product label

image descriptionimage descriptionimage description

SALYNTRA 
salicylic acid gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:83592-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83592-125-6060 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2024
Labeler - True Marker Pharmaceuticals, Inc. (119046582)
Registrant - True Marker Pharmaceuticals, Inc. (119046582)

Revised: 1/2024
Document Id: 0fcbbc45-9ba4-a413-e063-6294a90a67ba
Set id: ad95f441-40ae-47cf-ab75-baeaa9d6a2fa
Version: 3
Effective Time: 20240125
 
True Marker Pharmaceuticals, Inc.