ACNE CLEANSER W/ SALICYLIC ACID- salicylic acid cream

Acne Cleanser W/ Salicylic Acid by

Drug Labeling and Warnings

Acne Cleanser W/ Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by Allure Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Salicylic Acid 2%

PURPOSE

Acne Treatment

INDICATIONS & USAGE

Uses: Treats acne

dries up acne

help prevent new acne

WARNINGS

For external use only.

DO NOT USE

Do not use :

on the broken skin

if pregnant or lactating

WHEN USING

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.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Physician's Aesthetic Research, Inc Distr.

San Clemente, CA 92672

www.lucrece.com

Made in USA

INGREDIENTS AND APPEARANCE

ACNE CLEANSER W/ SALICYLIC ACID 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4107-1	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2017

Labeler - Allure Labs, Inc (926831603)

Registrant - Allure Labs, Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs, Inc		926831603	manufacture(62742-4107)