Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c41dfa45-a018-435d-938b-d71c12080c29
Route
TOPICAL
Published
Effective Date 2014-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Arachidyl Alcohol Arachidyl Glucoside Docosanol Butylated Hydroxytoluene Bis-phenylpropyl Dimethicone (15 Cst) C12-15 Alkyl Benzoate C13-14 Isoparaffin Cetostearyl Alcohol Cetearyl Glucoside Citric Acid Monohydrate Dimethicone Edetate Disodium Ethylhexylglycerin Glycerin Soybean Isoceteth-20 Laureth-7 Methyl Gluceth-20 Phenoxyethanol Polyacrylamide (1300000 Mw) Ppg-15 Stearyl Ether Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-11-30
Description

SALICYLIC ACID 0.5%

Purpose

ACNE MEDICATION

Medication Information

Purpose

ACNE MEDICATION

Description

SALICYLIC ACID 0.5%

Uses

FOR THE TREATMENT OF ACNE

Warnings

FOR EXTERNA USE ONLY

Directions
  • CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION
  • 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 INCREASE TO TWO TO THREE TIMES DAILY, IF NEEDED, OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APLICATION TO ONCE A DAY OR EVERY OTHER DAY
Label Copy

Active Ingredient

SALICYLIC ACID 0.5%

Inactive Ingredients

ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BHT, BIS-PHENYLPROPYL DIMETHICONE, C12-15 ALKYL BENZOATE, C13-14 ISOPARAFFIN, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, CITRIC ACID, DIMETHICONE, DISODIUM EDTA, ETHYLENE/ACRYLIC ACID COPOLYMER, ETHYLHEXYLGLYCERIN, FRAGRANCE (PARFUM), GLYCERIN, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, ISOCETETH-20, LAURETH-7, METHYL GLUCETH-20, PHENOXYETHANOL, PPG-15 STEARYL ETHER, SODIUM HYDROXIDE, WATER (AQUA)

Questions Or Comments?

1-800-746-7287

When Using This Product
  • USING OTHER TOPICAL ACNE MDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.
  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER
Keep Out of Reach of Children

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Structured Label Content

Uses (USES)

FOR THE TREATMENT OF ACNE

Purpose (PURPOSE)

ACNE MEDICATION

Warnings (WARNINGS)

FOR EXTERNA USE ONLY

Directions (DIRECTIONS)
  • CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION
  • 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 INCREASE TO TWO TO THREE TIMES DAILY, IF NEEDED, OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APLICATION TO ONCE A DAY OR EVERY OTHER DAY
Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SALICYLIC ACID 0.5%

Inactive Ingredients (INACTIVE INGREDIENTS)

ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BHT, BIS-PHENYLPROPYL DIMETHICONE, C12-15 ALKYL BENZOATE, C13-14 ISOPARAFFIN, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, CITRIC ACID, DIMETHICONE, DISODIUM EDTA, ETHYLENE/ACRYLIC ACID COPOLYMER, ETHYLHEXYLGLYCERIN, FRAGRANCE (PARFUM), GLYCERIN, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, ISOCETETH-20, LAURETH-7, METHYL GLUCETH-20, PHENOXYETHANOL, PPG-15 STEARYL ETHER, SODIUM HYDROXIDE, WATER (AQUA)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-746-7287

When Using This Product (WHEN USING THIS PRODUCT)
  • USING OTHER TOPICAL ACNE MDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.
  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER
Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:52.116758 · Updated: 2026-03-14T22:53:53.333843