SALYNTRA

Manufacturer
True Marker Pharmaceuticals, Inc.
Effective date
2024-01-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:12:31

Label at a glance#

ProductSALYNTRA
Active ingredientSALICYLIC ACID
Label structure7 sections

Indications and 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.

Dosage and administration

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 m...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

salicylic acid 6%

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

hydroxypropyl cellulose, propylene glycol

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83592-125-60GM - Gram83592-125deaf25aa-a7c4-41d9-9807-46596039a65b12024-04-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83592-12583592-125-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
27eb84f0-2726-5236-e063-6394a90afc8dad95f441-40ae-47cf-ab75-baeaa9d6a2fa2024-11-27WarningsExact identifier
spl set id: ad95f441-40ae-47cf-ab75-baeaa9d6a2fa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.