SALICYLACNE-1% CLEARING GEL- salicylic acid gel 
Valley of the Sun Cosmetics

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.

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Salicylacne-1% Clearing Gel

Active Ingredients

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

Use for treatment of acne

Warning

For external use only

Do not use

Allergy alert: Do not use this product if you have a known allergy to salicylic acid

When using this product

Skin irritation and dryness is more likely occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Keep out of reach of children

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

Directions

Apply with a cotton ball, sweeping gently over face and neck (Cover the entire affected area with a thin layer) one to two times daily. If dryness or peeling occurs, reduce usage to every other day. It is best for normal, dry, combination and oily skin.

Inactive ingredients

Water(aqua), Propylene glycol, Glycerin, Acetyl glutathione (glutamine), Acrylates/C10-30 alkyl acrylates crosspolymer, Denatured alcohol (40-B), Benzoyl peroxide, Lactic acid, Polysorbate 20, Melaleuca alternifolia (*organic tea tree) leaf oil, Camelia sinesis (*organic green tea)leaf extract, Retinyl Palmitate (vitamin A), Carica (*organic papaya) fruit extract, Sodium ascorbyl phosphate (vitamin C), Bromelain (*organic pineapple steam leaf), Sodium PCA, Allium sativum (*organic garlic) oil, Citrus medica limonium (*organic lemon) fruit extract), Sodium hydroxide, Phenoxyethanol, Glycolic acid, Fragrance parfum

Package Label

Label

SALICYLACNE-1% CLEARING GEL 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76523-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
(2S)-3-PHENYLPROPANE-1,2-DIOL (UNII: 6PQ7U3G5W6)  
ALLIUM SATIVUM WHOLE (UNII: IIF21WT8O3)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZOYL PEROXIDE (UNII: W9WZN9A0GM)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
SODIUM PIDOLATE (UNII: 1V74VH163T)  
LACTIC ACID (UNII: 33X04XA5AT)  
GLUTAMINE (UNII: 0RH81L854J)  
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
ALCOHOL (UNII: 3K9958V90M)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
VITAMIN A (UNII: 81G40H8B0T)  
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)  
STEM BROMELAIN (UNII: ZLM4P8929R)  
CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
Product Characteristics
Color    Score    
ShapeROUNDSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76523-107-0259.15 mL in 1 JAR; Type 0: Not a Combination Product06/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/17/2021
Labeler - Valley of the Sun Cosmetics (176470664)
Registrant - Valley of the Sun Cosmetics (176470664)
Establishment
NameAddressID/FEIBusiness Operations
Valley of the Sun Cosmetics LLC176470664manufacture(76523-107)

Revised: 6/2021
Document Id: c4fa57b3-1899-25d2-e053-2995a90a1cb8
Set id: c4fa57b3-1898-25d2-e053-2995a90a1cb8
Version: 1
Effective Time: 20210617
 
Valley of the Sun Cosmetics