Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 55f614ee-f0fb-425d-aa5e-f90cad51c285
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Gluconolactone Niacinamide Butylene Glycol Glycolic Acid Sodium Hydroxide Glycerin Methyl Gluceth-20 Hydroxyethyl Cellulose, Unspecified Caprylyl Glycol Glycyrrhizinate Dipotassium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01
Description

Salicylic acid 2%

Purpose

Acne treatment

Medication Information

Purpose

Acne treatment

Description

Salicylic acid 2%

Use
  • for the treatment of acne
  • helps clear up acne blemishes and allows skin to heal
Section 51945-4

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually ingrease to two or three times dialy if neded or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other dayl
Active Ingredient



Salicylic acid 2%

Inactive Ingredients

water, gluconolactone, niacinamide, butylene glycol, glycolic acid, sodium hydroxide, glycerin, methyl gluceth-20, hydroxyethylcellulose, caprylyl glycol, dipotassium glycyrrhizate

Questions Or Comments?

Call toll-free 1-800-946-4453

When Using This Product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. 

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use
  • for the treatment of acne
  • helps clear up acne blemishes and allows skin to heal
Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually ingrease to two or three times dialy if neded or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other dayl
Active Ingredient (Active ingredient)



Salicylic acid 2%

Inactive Ingredients (Inactive ingredients)

water, gluconolactone, niacinamide, butylene glycol, glycolic acid, sodium hydroxide, glycerin, methyl gluceth-20, hydroxyethylcellulose, caprylyl glycol, dipotassium glycyrrhizate

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-946-4453

When Using This Product (When using this product)

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. 

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:37.284594 · Updated: 2026-03-14T23:02:16.200124