Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0c07e6e9-18c1-20da-e063-6294a90aa3c8
Route
TOPICAL
Published
Effective Date 2023-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Rosemary Matricaria Recutita Flowering Top Allantoin Caprylyl Glycol Ethylhexylglycerin Plantago Ovata Seed Diethylene Glycol Monoethyl Ether Starch, Wheat Hexylene Glycol Hamamelis Virginiana Leaf Water Alcohol Phenoxyethanol Sodium Pyrrolidone Carboxylate Water Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Glycyrrhizinate Dipotassium Niacinamide Glycerin Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-08
Description

Active Ingredient: Salicylic Acid 1%

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:

Cleanse the skin thoroughly before applying medication. Avoid eye area. If excessive dryness or peeling occurs, reduce application to once a day.

Description

Active Ingredient: Salicylic Acid 1%

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), Alcohol Denat, Hamamelis Virginiana (Witch Hazel) Leaf Water, Ethoxydiglycol, Niacinamide, Glycerin, Polysorbate 20, Plantago Ovata (Indian Plantin) Seed Extract, Sodium PCA, Hydrolyzed Wheat Protein, Hydrolyzed Wheat Starch, Phenoxyethanol, Caprylyl Glycol, Ethylhexyl Glycerin, Rosmarinus Officinalis ( Rosemary) Leaf Extract, Chamomilla Recutita ( Chamomile) Flower Extract, Hexylene Glycol, Allantoin, Dipotassium Glycyrrhizate.

Section 51945-4

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredient:

Salicylic Acid 1%

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:

Cleanse the skin thoroughly before applying medication. Avoid eye area. If excessive dryness or peeling occurs, reduce application to once a 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), Alcohol Denat, Hamamelis Virginiana (Witch Hazel) Leaf Water, Ethoxydiglycol, Niacinamide, Glycerin, Polysorbate 20, Plantago Ovata (Indian Plantin) Seed Extract, Sodium PCA, Hydrolyzed Wheat Protein, Hydrolyzed Wheat Starch, Phenoxyethanol, Caprylyl Glycol, Ethylhexyl Glycerin, Rosmarinus Officinalis ( Rosemary) Leaf Extract, Chamomilla Recutita ( Chamomile) Flower Extract, Hexylene Glycol, Allantoin, Dipotassium Glycyrrhizate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient:

Salicylic Acid 1%

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: 2026-02-15T12:02:29.420717 · Updated: 2026-03-14T23:02:04.460294