Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5084f352-96ef-4c05-8bdf-4d4fbe70c36a
Route
TOPICAL
Published
Effective Date 2018-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 mg)
Inactive Ingredients
Water Hamamelis Virginiana Top Water Glycerin Polysorbate 20 Comfrey Root Plantago Ovata Seed Sodium Pyrrolidone Carboxylate Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Rosemary Chamomile Hexylene Glycol Allantoin Glycyrrhizinate Dipotassium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-11-09
Description

Active Ingredient:  Salicylic Acid 1%

Medication Information

Warnings and Precautions

Warnings: For external use only

Indications and Usage

Uses:

  • For the treatment of acne.
  • Eliminates pore clogging impurities.
  • For all skin types.

Dosage and Administration

Directions:

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

Description

Active Ingredient:  Salicylic Acid 1%

Section 50565-1

Keep out of the reach of children.

Section 50567-7
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
  • If excessive irritation occurs reduce application to once a day.

Section 51727-6

Water (Aqua), SD Alcohol 40-B (Alcohol Denat.), Hamamelis Virginiana (Witch Hazel)  Water, Glycerine, Polysorbate 20, Symphytum Officinale (Comfrey)  Extract, 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

Advanced Skin Care

Los Angeles, California 90025

877-20-CLEAR

clearogen.com

made in USA

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredient: Salicylic Acid 1%

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • For the treatment of acne.
  • Eliminates pore clogging impurities.
  • For all skin types.

Dosage and Administration (34068-7)

Directions:

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

Warnings and Precautions (34071-1)

Warnings: For external use only

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50567-7 (50567-7)
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
  • If excessive irritation occurs reduce application to once a day.

Section 51727-6 (51727-6)

Water (Aqua), SD Alcohol 40-B (Alcohol Denat.), Hamamelis Virginiana (Witch Hazel)  Water, Glycerine, Polysorbate 20, Symphytum Officinale (Comfrey)  Extract, 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)

Advanced Skin Care

Los Angeles, California 90025

877-20-CLEAR

clearogen.com

made in USA

Section 55105-1 (55105-1)

Purpose: Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient: Salicylic Acid 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:41.014888 · Updated: 2026-03-14T22:55:19.604592