SALICYLIC ACID- salicylic acid 12% cream

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by SANSAR, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 12%

Purpose

Corn and callus remover

Uses

• for the removal of corns and calluses
• Relieves pain by removing corns and calluses

Warnings

For external use only.

DO NOT USE

Do not use in Children under 2 years of age unless directed by doctor.

When using this product

• Do not get into eyes

Stop use and ask doctor if 

• irritation occurs or allergic reaction

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions 

Apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor. Rub it until completely absorbed.

Inactive Ingredients 

Purified water, Isopropyl Palmitate, Propylene Glycol, Cetyl Alcohol, Disodium EDTA, Glyceryl Stearate, Aloe Vera Gel, Urea, Triethanolamine, Lanolin oil, Allantoin, Carbomer, Iodopropynyl Butylcarbamate, Retinyl Palmitate, Coconut Oil, Tea Tree Oil, Peppermint Oil, Geranium Oil, Manuka Oil, Vitamin D, Tocopheryl Acetate (Vitamin E).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 
salicylic acid 12% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83691-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
UREA (UNII: 8W8T17847W)
TROLAMINE (UNII: 9O3K93S3TK)
LANOLIN OIL (UNII: OVV5IIJ58F)
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
COCONUT OIL (UNII: Q9L0O73W7L)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
PALMAROSA OIL (UNII: 0J3G3O53ST)
MANUKA OIL (UNII: M6QU9ZUH2X)
VITAMIN D (UNII: 9VU1KI44GP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83691-008-01	1 in 1 CARTON	05/02/2025
1		57 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 83691-008-02	2 in 1 CARTON	05/02/2025
2		57 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M030	05/02/2025

Labeler - SANSAR, LLC (127927811)