Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0bf4c2d8-2fbf-a1c4-e063-6294a90ac130
Route
TOPICAL
Published
Effective Date 2023-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
C12-15 Alcohols Caprylyl Glycol Sodium Hydroxide 1-ethoxyundecane Water Cocamidopropyl Betaine Butylene Glycol Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Aloe Vera Leaf Rosemary (c10-c16)alkyldimethylamine Oxide Starch, Wheat Ethylhexylglycerin Sodium Chloride Phenoxyethanol Hexylene Glycol Lavandula Angustifolia Subsp. Angustifolia Leaf Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-07
Description

Active Ingredient: Salicylic Acid 2%

Medication Information

Warnings and Precautions

Warning: For external use only

Indications and Usage

Uses: For the treatment of acne

Gently cleanses and maintains optimal moisture balance.

For all skin types

Dosage and Administration

Direction:

Use daily. Thoroughly lather foam over wet skin, rinse well and pat dry. Avoid eye area. If excessive dryness or peeling occurs, reduce application to every other day.

Description

Active Ingredient: Salicylic Acid 2%

Section 50565-1

Keep out of reach of children.

Section 50566-9

If excessive dryness or peeling occurs

Section 50567-7

Avoid eye area

Section 50570-1

If excessive dryness or peeling occurs

Section 51727-6

Inactive Ingredient:

Water (Aqua), Alkyl (C10-16) Ether Sulfate Sodium Salt, Cocamidopropyl Betaine, Butylene Glycol, Hydrolyzed Wheat Protein, Alcohol (C12-15 Ln. saturated), Ethoxylate, Hydrolyzed Wheat Starch, Caprylyl Glycol, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis ( Rosemary) Leaf Extract, Sodium Hydroxide, Ethylhexyl Glycerin, Hexylene Glycol, Sodium Chloride, Lavandula Angustifolia ( Lavender) Leaf Oil O.E., Glycerin.

Section 51945-4

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredient:

Salicylic Acid 2%

Section 60561-8

Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin.

If this occurs, only one medication should be used unless directed by a doctor.

Structured Label Content

Indications and Usage (34067-9)

Uses: For the treatment of acne

Gently cleanses and maintains optimal moisture balance.

For all skin types

Dosage and Administration (34068-7)

Direction:

Use daily. Thoroughly lather foam over wet skin, rinse well and pat dry. Avoid eye area. If excessive dryness or peeling occurs, reduce application to every other day.

Warnings and Precautions (34071-1)

Warning: For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

If excessive dryness or peeling occurs

Section 50567-7 (50567-7)

Avoid eye area

Section 50570-1 (50570-1)

If excessive dryness or peeling occurs

Section 51727-6 (51727-6)

Inactive Ingredient:

Water (Aqua), Alkyl (C10-16) Ether Sulfate Sodium Salt, Cocamidopropyl Betaine, Butylene Glycol, Hydrolyzed Wheat Protein, Alcohol (C12-15 Ln. saturated), Ethoxylate, Hydrolyzed Wheat Starch, Caprylyl Glycol, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis ( Rosemary) Leaf Extract, Sodium Hydroxide, Ethylhexyl Glycerin, Hexylene Glycol, Sodium Chloride, Lavandula Angustifolia ( Lavender) Leaf Oil O.E., Glycerin.

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)

Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin.

If this occurs, only one medication should be used unless directed by a doctor.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:29.416425 · Updated: 2026-03-14T23:02:04.460294