SPL v1
SPL
SPL Set ID 074079cd-866d-0af0-e063-6394a90a7214
Route
TOPICAL
Published
Effective Date 2023-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 mg)
Inactive Ingredients
Water Sodium Hydroxide Edetate Disodium Anhydrous Glycolic Acid Sodium C14-16 Olefin Sulfonate Sorbitol Gluconolactone Chlorphenesin Cocamidopropyl Hydroxysultaine Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-09
Description

Salicylic Acid (1%)

Purpose

Acne treatment

Medication Information

Purpose

Acne treatment

Description

Salicylic Acid (1%)

Use

For the treatment of acne.

Label

Warnings

For external use only.

Directions
  • Wet body
  • Gently massage over body for 20-30 seconds
  • Rinse thoroughly and pat dry
  • Recommended for daily use
Active Ingredient

Salicylic Acid (1%)

Other Information

Store at room temperature

Inactive Ingredients

Water

Sodium C14-16 Olefin Sulfonate

Cocamidopropyl Hydroxysultaine

Sorbitol

Gluconolactone

Chlorphenesin

Sodium Hydroxide

Acrylates Copolymer

Disodium EDTA

Glycolic Acid

When Using This Product
  • Avoid contact with eyes. If contact occurs, immediately fulsh with water.
  • Skin irritation and dryness is more likely to occur if you use another topical ance 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.

Label (label)

Purpose

Acne treatment

Warnings

For external use only.

Directions
  • Wet body
  • Gently massage over body for 20-30 seconds
  • Rinse thoroughly and pat dry
  • Recommended for daily use
Active Ingredient (Active ingredient)

Salicylic Acid (1%)

Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

Water

Sodium C14-16 Olefin Sulfonate

Cocamidopropyl Hydroxysultaine

Sorbitol

Gluconolactone

Chlorphenesin

Sodium Hydroxide

Acrylates Copolymer

Disodium EDTA

Glycolic Acid

When Using This Product (When using this product)
  • Avoid contact with eyes. If contact occurs, immediately fulsh with water.
  • Skin irritation and dryness is more likely to occur if you use another topical ance 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: 2026-02-15T12:01:20.866465 · Updated: 2026-03-14T23:01:22.645369