OTC Medication Information: Acne Cleanser W/ Salicylic Acid

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.

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 W/ SALICYLIC ACID salicylic acid cream

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

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

Inactive Ingredients Ingredient Name Strength WATER SORBITOL AMMONIUM LAURYL SULFATE CETYL ALCOHOL STEARYL ALCOHOL PPG-12/SMDI COPOLYMER PHENOXYETHANOL CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL MELALEUCA ALTERNIFOLIA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62742-4107-1 177 mL in 1 BOTTLE, PLASTIC None

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	Operations
Allure Labs, Inc		926831603	manufacture (62742-4107)

Revised: 12/2017 Allure Labs, Inc