Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID bfeced33-a630-4f1d-9ecf-33450bd26ae9
Route
TOPICAL
Published
Effective Date 2014-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 mg)
Inactive Ingredients
Cetyl Alcohol Tea Tree Oil Stearyl Alcohol Ammonium Lauryl Sulfate Water Sorbitol Ppg-12/smdi Copolymer Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-05-02

Description

Active Ingredient: Salicylic Acid 2%


Medication Information

Warnings and Precautions

Warnings - For external use only

Indications and Usage

Uses - Fot the treatment of acne

Dosage and Administration

Directions - Emulsify cleanser with lukewarm water and gently massage onto the skin, avoiding the eye area. Rinse well and pat dry. Not recommended for those with asprin / NASID allergies.

Description

Active Ingredient: Salicylic Acid 2%

Section 50565-1

Keep out of reach of children. If swallowed , get medical help or contact a Poison Cotrol Center right away.

Section 50566-9

Stop use and ask a doctor -

  • if severe skin irritation occurs
  • Using other topical medication at the same time
Section 50567-7

When using this product -

  • Avoid contact with the eyes, lips and mouth
  • 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.
  • If sensitive to the sun or when increased sun exposure is expected use a sunscreen
Section 50570-1

Do not use if you - have very sensitive skin

Section 51727-6

Inactive Ingredients -

Water (Aqua), Sorbitol, Cetyl Alcohol, Stearyl Alcohol, PPG12/'SMDI Copolymer, Ammonium Lauryl Sulfate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Melaleuca (Tea Tree) Alternifolia Leaf Oil

Section 51945-4

Manufactured for Dermaquest®, Inc.

Hayward, CA - 94544

1272 GK,NL Made in USA

Dermaquest Inc.

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredient: Salicylic Acid 2%


Structured Label Content

Indications and Usage (34067-9)

Uses - Fot the treatment of acne

Dosage and Administration (34068-7)

Directions - Emulsify cleanser with lukewarm water and gently massage onto the skin, avoiding the eye area. Rinse well and pat dry. Not recommended for those with asprin / NASID allergies.

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 Cotrol Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor -

  • if severe skin irritation occurs
  • Using other topical medication at the same time
Section 50567-7 (50567-7)

When using this product -

  • Avoid contact with the eyes, lips and mouth
  • 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.
  • If sensitive to the sun or when increased sun exposure is expected use a sunscreen
Section 50570-1 (50570-1)

Do not use if you - have very sensitive skin

Section 51727-6 (51727-6)

Inactive Ingredients -

Water (Aqua), Sorbitol, Cetyl Alcohol, Stearyl Alcohol, PPG12/'SMDI Copolymer, Ammonium Lauryl Sulfate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Melaleuca (Tea Tree) Alternifolia Leaf Oil

Section 51945-4 (51945-4)

Manufactured for Dermaquest®, Inc.

Hayward, CA - 94544

1272 GK,NL Made in USA

Dermaquest Inc.

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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