Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3df8f746-03a2-464c-a83a-8d59d7f2a117
Route
TOPICAL
Published
Effective Date 2018-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Butylene Glycol Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) C12-15 Alcohols Caprylyl Glycol Phenoxyethanol Aloe Vera Leaf Rosemary Sodium Hydroxide Ethylhexylglycerin Hexylene Glycol Sodium Chloride Lavender Oil Glycerin

Identifiers & Packaging

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

Description

Active Ingredient:  Salicylic Acid 2%


Medication Information

Warnings and Precautions

Warnings: For external use only.

Indications and Usage

Directions:

  • 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.

Dosage and Administration

Uses:

  • For the treatment of acne
  • Gently cleanses and maintains optimal moisture balance
  • For all skin types

Description

Active Ingredient:  Salicylic Acid 2%

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

Section 51727-6

Water (Aqua), Alkyl (C10-16) Ether Sulfate Sodium Salt, Cocamidopropyl Betaine, Butylene Glycol, Hydrolyzed Wheat Protein, Alcohols (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

Advanced Skin & Hair

Los Angeles, California 90025

877-30-CLEAR

clearogen.com

Made In USA

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredient: Salicylic Acid 2%


Structured Label Content

Indications and Usage (34067-9)

Directions:

  • 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.

Dosage and Administration (34068-7)

Uses:

  • For the treatment of acne
  • Gently cleanses and maintains optimal moisture balance
  • For all skin types

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

Section 51727-6 (51727-6)

Water (Aqua), Alkyl (C10-16) Ether Sulfate Sodium Salt, Cocamidopropyl Betaine, Butylene Glycol, Hydrolyzed Wheat Protein, Alcohols (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)

Advanced Skin & Hair

Los Angeles, California 90025

877-30-CLEAR

clearogen.com

Made In USA

Section 55105-1 (55105-1)

Purpose: Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient: Salicylic Acid 2%


Advanced Ingredient Data


Raw Label Data

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