SPL v1
SPL
SPL Set ID 61c880b3-af2b-4251-b925-393e8567479a
Route
TOPICAL
Published
Effective Date 2025-01-21
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (6 g)
Inactive Ingredients
Hydroxypropyl Cellulose, Unspecified Propylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-01-14

Description

Salicylic Acid 6%


Medication Information

Description

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.

Section 42229-5

Questions or comments? Call 1-888-711-7116.

Section 55105-1

Warning

For external use only. Avoid contact with eyes and 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 Salicylic Acid 6% Gel thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated (soaked in water) for at least five minutes prior to application. The medication 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 Salicylic Acid 6% Gel will usually

maintain the remission. Unless hands are being treated, hands should be rinsed thoroughly after application.

Product Label

Active Ingredient

Salicylic Acid 6%

Other Information 

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

Inactive Ingredient 

Hydroxypropyl Cellulose, Propylene Glycol


Structured Label Content

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.

Section 42229-5 (42229-5)

Questions or comments? Call 1-888-711-7116.

Section 55105-1 (55105-1)

Warning

For external use only. Avoid contact with eyes and 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 Salicylic Acid 6% Gel thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated (soaked in water) for at least five minutes prior to application. The medication 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 Salicylic Acid 6% Gel will usually

maintain the remission. Unless hands are being treated, hands should be rinsed thoroughly after application.

Product Label (Product label)

Active Ingredient

Salicylic Acid 6%

Other Information 

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

Inactive Ingredient  (Inactive ingredient )

Hydroxypropyl Cellulose, Propylene Glycol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)