OTC Medication Information: Acne Clarifying Cream

ACNE CLARIFYING CREAM- 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.

Salicylic Acid 2%

Acne Treatment Cream

Uses: Treats Acne, dries up Acne, helps prevent new acne

For external use only

do not use:

on a broken skin

if pregnant or lactating

when using this product:

avoid unnecessary sun exposure and use a sunscreen

do not use in or near the eyes

using other acne topical drugs at the same time or right after use of this product may increase dryness or irritation of the skin

stop use and ask a doctor if too much irritation or sensitivity developes or increases

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

Directions: Cleanse the skin thoroughly, then apply a hydration serum before applying the acne clarifying cream. Cover the affected and surrounding area with a thin layer. Avoid eye area. For evening or night use only

Store at 20-25 C (68-77 F)

Water (Aqua), Glycolic Acid, Caprylic/Capric triglyceride, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol and Dicetyl Phospahte, Ceteth 10 Phosphate, Azelaic Acid, Glycerin, Hexyl Laurate, Lactic Acid, Sorbitol, Ammonium Hydroxide, Butylene Glycol, Cetyl Alcohol, PPG-12/SMDI Copolymer, Sodium Hyaluronate, Yeast (Faex) Extract, Propylene Glycol, Symphytum Officinale Extract, Plantago Ovata Seed Extract, Amino Acids, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Stearic Acid, Tocopheryl Acetate, Dimethicone, Imperata Cylindrica Root Extract, Hydrolyzed Wheat Protein, Hydrolyzed Wheat Starch, Butyrospermum Parkii (Shea Butter), Mangifera Indica (Mango) Seed Butter, Xanthan Gum, Magnisium Aluminium Sulphate, Glycine, Lavandula Angustifolia (Lavender)Oil, Ceramides, Disodium EDTA

Physicians Aesthetic Research, Inc., Distr.

San Clemente, CA 92672

Made in U.S.A.

www.lucrece.com

ACNE CLARIFYING CREAM salicylic acid cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4113 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 GLYCOLIC ACID MEDIUM-CHAIN TRIGLYCERIDES CETEARYL OLIVATE SORBITAN OLIVATE CETOSTEARYL ALCOHOL DIHEXADECYL PHOSPHATE CETETH-10 PHOSPHATE AZELAIC ACID GLYCERIN HEXYL LAURATE LACTIC ACID SORBITOL AMMONIA BUTYLENE GLYCOL CETYL ALCOHOL PPG-12/SMDI COPOLYMER HYALURONATE SODIUM YEAST PROPYLENE GLYCOL SYMPHYTUM OFFICINALE WHOLE PLANTAGO OVATA SEED AMINO ACIDS PHENOXYETHANOL CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE IMPERATA CYLINDRICA ROOT HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) SHEA BUTTER MANGIFERA INDICA SEED BUTTER XANTHAN GUM GLYCINE LAVENDER OIL CERAMIDE 1 EDETATE DISODIUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62742-4113-1 59 mL in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/04/2017

Labeler — Allure Labs, Inc (926831603)

Revised: 12/2017 Allure Labs, Inc