ACNE CLEANSER W/ SALICYLIC ACID- salicylic acid cream 
Allure Labs, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active Ingredient: Salicylic Acid 2%

Acne Treatment

Uses: Treats acne

dries up acne

help prevent new acne

For external use only.

Do not use :

on the broken skin

if pregnant or lactating

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

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

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.

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

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.

Physician's Aesthetic Research, Inc Distr.

San Clemente, CA 92672

www.lucrece.com

Made in USA

Acne Cleanser 60

ACNE CLEANSER W/ SALICYLIC ACID 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4107-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/01/2017
Labeler - Allure Labs, Inc (926831603)
Registrant - Allure Labs, Inc (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs, Inc926831603manufacture(62742-4107)

Revised: 12/2017
Document Id: 90190c04-8a2c-40ab-be29-1ff26c488935
Set id: 6f831f09-03c2-49a4-b677-626005777126
Version: 1
Effective Time: 20171201
 
Allure Labs, Inc