Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID b61a3f74-a588-47f4-b4a5-c8f97f98d9dd
Route
TOPICAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Water Coco-betaine Propanediol Peg-120 Methyl Glucose Dioleate Sodium Chloride Sodium Cocoyl Glycinate Dipropylene Glycol Zinc Gluconate Sodium Hydroxide Sodium Benzoate Phenoxyethanol Copper Gluconate Caprylyl Glycol Tetrasodium Glutamate Diacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-15 Until 2023-06-01
Description

Salicylic acid...0.5%

Purpose

Acne treatment

Medication Information

Purpose

Acne treatment

Description

Salicylic acid...0.5%

Use

for the treatment of acne

Section 51945-4

Warnings

For external use only

Directions
  • use twice daily
  • wet face, then work product into a lather
  • massage onto face avoiding the eyes
  • rinse well
Active Ingredient

Salicylic acid...0.5%

Inactive Ingredients

water, coco-betaine, propanediol, PEG-120 methyl glyucose dioleate, sodium chloride, sodium cocoyl glycinate, dipropylene glycol, zinc gluconate, bifida ferment lysate, sodium hydroxide, sodium benzoate, phenoxyethanol, copper gluconate, caprylyl glycol, tetrasodium glutamate diacetate, fragrance

When Using This Product

kin 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

Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions
  • use twice daily
  • wet face, then work product into a lather
  • massage onto face avoiding the eyes
  • rinse well
Active Ingredient (Active ingredient)

Salicylic acid...0.5%

Inactive Ingredients (Inactive ingredients)

water, coco-betaine, propanediol, PEG-120 methyl glyucose dioleate, sodium chloride, sodium cocoyl glycinate, dipropylene glycol, zinc gluconate, bifida ferment lysate, sodium hydroxide, sodium benzoate, phenoxyethanol, copper gluconate, caprylyl glycol, tetrasodium glutamate diacetate, fragrance

When Using This Product (When using this product)

kin 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: 2026-02-15T12:02:28.825637 · Updated: 2026-03-14T23:02:04.460294