REPLENIX ACNE GLY-SAL 2-2 FOAMING CLEANSER- salicylic acid liquid 
Topiderm, Inc.

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Replenix® Acne Solutions Gly-Sal® 2-2 Foaming Cleanser

Drug Facts

Active ingredient

Salicylic Acid USP, 2%

Purpose

Acne medication

Uses

Skin cleanser for the treatment of acne.

Warnings

For external use only

Keep away from eyes, lips, and mouth. Using other topical medications, while using this product or immediately thereafter, may increase dryness or irritation. If this occurs discontinue use and see your doctor.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center.

Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter because some individuals may be more sensitive to sunlight.

Directions

Wet affected area, apply, and rinse well.

Inactive ingredients

Water, Sodium Lauroyl Sarcosinate, Sodium Methyl Cocoyl Taurate, PEG-7 Glyceryl Cocoate, Disodium Cocoamphodiacetate, Potassium Hydroxide, Glycolic Acid, Green Tea Extract, Cucumber Extract, Zinc PCA, Copper PCA, Willow Bark Extract, Hydroxyethylcellulose, Phenoxyethanol, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label

REPLENiX®
ACNE SOLUTIONS

Gly/Sal® 2-2
Foaming
Cleanser

Glycolic Acid 2%
Salicylic Acid USP, 2%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label
REPLENIX ACNE GLY-SAL 2-2 FOAMING CLEANSER 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-929
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)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CUCUMBER (UNII: YY7C30VXJT)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
COPPER PIDOLATE (UNII: 497G7G1SL1)  
WILLOW BARK (UNII: S883J9JDYX)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-929-06200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM00603/15/2016
Labeler - Topiderm, Inc. (049121643)
Registrant - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm, Inc.049121643MANUFACTURE(51326-929)
Establishment
NameAddressID/FEIBusiness Operations
Topix Pharmaceuticals, Inc.117745066PACK(51326-929)

Revised: 12/2019
Document Id: ef33baaf-fbab-483d-9c2a-fbce487ce9be
Set id: 811dbf95-2b39-45c5-99a2-33c3c9d19570
Version: 4
Effective Time: 20191219
 
Topiderm, Inc.