Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e9c1703f-840b-4ec1-960a-71c20dfb82ba
Route
TOPICAL
Published
Effective Date 2015-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Alcohol Isoceteth-20 Sulisobenzone Fd&c Red No. 40 Denatonium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-03-02
Description

SALICYLIC ACID 2.0%

Purpose

ACNE TREATMENT

Medication Information

Purpose

ACNE TREATMENT

Description

SALICYLIC ACID 2.0%

Uses

FOR THE TREATMENT OF ACNE

Warnings

FOR EXTERNAL USE ONLY

  • FLAMMABLE
  • KEEP AWAY FROM FIRE OR HEAT SOURCE
Directions
  • CLEANSE SKIN THOROUGHLY
  • MOISTEN A COTTON BALL WITH PRODUCT AND COVER AFFECTED AREA ONE TO THREE TIMES DAILY
  • DUE TO EXCESSIVE DRYING OF THE SKIN, START WITH ONE APPLICATION DAILY, INCREASING TO 2 OR 3 IF NEEDED OR AS DIRECTED BY A PHYSICIAN
  • IF PEELING OCCURS, REDUCE USE TO ONCE A DAY OR EVERY OTHER DAY
Label Copy

Active Ingredient

SALICYLIC ACID 2.0%

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

WATER (AQUA), ALCOHOL DENAT., ISOCETETH-20, FRAGRANCE (PARFUM), DIMETHICONE PROPYL PG-BETAINE, BENZOPHENONE-4, RED 4 (CI 14700), DENATONIUM BENZOATE

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Stop Using This Product and Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS

Ask Doctor Or Pharmacist Before Use If You Are

USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. iF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A DOCTOR

Structured Label Content

Uses (USES)

FOR THE TREATMENT OF ACNE

Purpose (PURPOSE)

ACNE TREATMENT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

  • FLAMMABLE
  • KEEP AWAY FROM FIRE OR HEAT SOURCE
Directions (DIRECTIONS)
  • CLEANSE SKIN THOROUGHLY
  • MOISTEN A COTTON BALL WITH PRODUCT AND COVER AFFECTED AREA ONE TO THREE TIMES DAILY
  • DUE TO EXCESSIVE DRYING OF THE SKIN, START WITH ONE APPLICATION DAILY, INCREASING TO 2 OR 3 IF NEEDED OR AS DIRECTED BY A PHYSICIAN
  • IF PEELING OCCURS, REDUCE USE TO ONCE A DAY OR EVERY OTHER DAY
Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SALICYLIC ACID 2.0%

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), ALCOHOL DENAT., ISOCETETH-20, FRAGRANCE (PARFUM), DIMETHICONE PROPYL PG-BETAINE, BENZOPHENONE-4, RED 4 (CI 14700), DENATONIUM BENZOATE

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS

Ask Doctor Or Pharmacist Before Use If You Are (ASK DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)

USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. iF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A DOCTOR

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:54.879145 · Updated: 2026-03-14T22:53:57.959732