SPL v2
SPL
SPL Set ID 1b808bcc-0751-4a24-9f9a-339563b56106
Route
TOPICAL
Published
Effective Date 2013-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Diethylene Glycol Monoethyl Ether Butylene Glycol Glycereth-7 Trimethyl Ether Aminomethylpropanol Potassium Azeloyl Diglycinate Syringa Vulgaris Whole Glycyrrhizinate Dipotassium Urea Angelica Sinensis Whole Avena Sativa Top Hamamelis Virginiana Root Bark/stem Bark Papain Betaine Calcium Pantothenate Proline Alanine Serine Magnesium Lactate Potassium Lactate Lecithin, Soybean Glycerin Maltodextrin Ethylhexylglycerin Sodium Citrate Xanthan Gum Hydroxyethyl Cellulose (100 Mpa.s At 2%) Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Edetate Disodium Magnesium Chloride Benzyl Alcohol Sorbic Acid Caprylyl Glycol Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-21
Description

ACTIVE INGREDIENT SALICYLIC ACID 2%

Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

USES

  • TREATS ACNE
  • DRIES UP ACNE PIMPLES
  • HELPS PREVENT NEW ACNE PIMPLES
Dosage and Administration

DIRECTIONS

  • ON CLEAN AND DRY SKIN, APPLY A SMALL AMOUNT EVENLY OVER THE AFFECTED AREAS.
  • AVOID THE DELICATE EYE AREA.
  • START WITH ONE APPLICATION DAILY THEN GRADUALLY INCREASE TO TWO TIMES DAILY IF NEEDED, OR AS DIRECTED BY A DOCTOR.
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.
  • CONSULT A PHYSICIAN BEFORE USE.
Description

ACTIVE INGREDIENT SALICYLIC ACID 2%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

Section 50567-7

WHEN USING THIS PRODUCT

  • SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.
  • 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.
Section 50570-1

DO NOT USE

  • IF YOU HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE
Section 51727-6

INGREDIENTS

aqua (water), ethoxydiglycol, butylene glycol, glycereth-7 trimethyl ether, aminomethylpropanol, potassium azeloyl, diglycinate, syringa vulgaris (lilac) leaf cell culture extract, dipotassium glycyrrhizate, urea, angelica sinensis extract, avena sativa (oat) extract, avena sativa (oat) kernel extract, hamamelis virginiana (witch hazel) , bark/leaf/twig extract, papain, betaine, calcium pantothenate, proline, Alanine, serine, magnesium lactate, potassium lactate, lecithin, glycerin, maltodextrin , ethylhexylglycerin, sodium citrate, xanthan gum, hydroxyethylcellulose, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, magnesium chloride, benzyl alcohol , sorbic acid, caprylyl glycol, phenoxyethanol, ethylhexylglycerin

Section 51945-4

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENT

SALICYLIC ACID 2%

Section 60561-8

Other Information

Store at 20-25 DEGREES CELCIUS (68-78 DEGREES FAHRENHEIT)

Structured Label Content

Indications and Usage (34067-9)

USES

  • TREATS ACNE
  • DRIES UP ACNE PIMPLES
  • HELPS PREVENT NEW ACNE PIMPLES
Dosage and Administration (34068-7)

DIRECTIONS

  • ON CLEAN AND DRY SKIN, APPLY A SMALL AMOUNT EVENLY OVER THE AFFECTED AREAS.
  • AVOID THE DELICATE EYE AREA.
  • START WITH ONE APPLICATION DAILY THEN GRADUALLY INCREASE TO TWO TIMES DAILY IF NEEDED, OR AS DIRECTED BY A DOCTOR.
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.
  • CONSULT A PHYSICIAN BEFORE USE.
Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT

  • SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.
  • 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.
Section 50570-1 (50570-1)

DO NOT USE

  • IF YOU HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE
Section 51727-6 (51727-6)

INGREDIENTS

aqua (water), ethoxydiglycol, butylene glycol, glycereth-7 trimethyl ether, aminomethylpropanol, potassium azeloyl, diglycinate, syringa vulgaris (lilac) leaf cell culture extract, dipotassium glycyrrhizate, urea, angelica sinensis extract, avena sativa (oat) extract, avena sativa (oat) kernel extract, hamamelis virginiana (witch hazel) , bark/leaf/twig extract, papain, betaine, calcium pantothenate, proline, Alanine, serine, magnesium lactate, potassium lactate, lecithin, glycerin, maltodextrin , ethylhexylglycerin, sodium citrate, xanthan gum, hydroxyethylcellulose, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, magnesium chloride, benzyl alcohol , sorbic acid, caprylyl glycol, phenoxyethanol, ethylhexylglycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

SALICYLIC ACID 2%

Section 60561-8 (60561-8)

Other Information

Store at 20-25 DEGREES CELCIUS (68-78 DEGREES FAHRENHEIT)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:35.994225 · Updated: 2026-03-14T22:53:25.926266