Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6f831f09-03c2-49a4-b677-626005777126
Route
TOPICAL
Published
Effective Date 2017-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Sorbitol Ammonium Lauryl Sulfate Cetyl Alcohol Stearyl Alcohol Ppg-12/smdi Copolymer Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Melaleuca Alternifolia Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-01

Description

Active Ingredient: Salicylic Acid 2%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Uses: Treats acne

dries up acne

help prevent new acne

Dosage and Administration

gently massage cleanser onto skin and remove with lukewarm water.

use once daily, alternating use with another, non drug cleanser.

if bothersome dryness or peeling occurs, reduce application to every other day.

Description

Active Ingredient: Salicylic Acid 2%

Section 50565-1

if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop useand ask a doctor if too much skin irritation or sensitivity develops or increase.

Section 50567-7

avoid unnecessary sun exposure and use a sunscreen.

do not use in or near the eyes.

not that using other topical acne drugs at the same time or right after use of this product may increase dryness or skin irritation.

Section 50570-1

Do not use :

on the broken skin

if pregnant or lactating

Section 51727-6

Inactive Ingredients: Water (Aqua), Sorbitol, Ammonium Lauryl Sulfate, Cetyl Alcohol, Stearyl Alcohol, PPG-12/SMDI Copolymer, Phenoxyethanol, CAprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

Section 51945-4

Physician's Aesthetic Research, Inc Distr.

San Clemente, CA 92672

www.lucrece.com

Made in USA

Section 55105-1

Acne Treatment

Section 55106-9

Active Ingredient: Salicylic Acid 2%

Section 60561-8

store at 19-24 C (66-75 F)


Structured Label Content

Indications and Usage (34067-9)

Uses: Treats acne

dries up acne

help prevent new acne

Dosage and Administration (34068-7)

gently massage cleanser onto skin and remove with lukewarm water.

use once daily, alternating use with another, non drug cleanser.

if bothersome dryness or peeling occurs, reduce application to every other day.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop useand ask a doctor if too much skin irritation or sensitivity develops or increase.

Section 50567-7 (50567-7)

avoid unnecessary sun exposure and use a sunscreen.

do not use in or near the eyes.

not that using other topical acne drugs at the same time or right after use of this product may increase dryness or skin irritation.

Section 50570-1 (50570-1)

Do not use :

on the broken skin

if pregnant or lactating

Section 51727-6 (51727-6)

Inactive Ingredients: Water (Aqua), Sorbitol, Ammonium Lauryl Sulfate, Cetyl Alcohol, Stearyl Alcohol, PPG-12/SMDI Copolymer, Phenoxyethanol, CAprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

Section 51945-4 (51945-4)

Physician's Aesthetic Research, Inc Distr.

San Clemente, CA 92672

www.lucrece.com

Made in USA

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient: Salicylic Acid 2%

Section 60561-8 (60561-8)

store at 19-24 C (66-75 F)


Advanced Ingredient Data


Raw Label Data

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