SALICYLIC ACID- salicylic acid gel 
Greenbrier International, 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.

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ACNE WASH

Drug Facts


Active Ingredients

Salicylic acid ............. 2%

Purpose

Acne Treatment

Uses

  • For the management of acne

Warnings

For external use only

Avoid contact with eyes, if contact occurs, flush thoroughly with water.

When using this product

  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • use twice daily
  • apply water to face and hands
  • dispense our Oil Free Acne Wash into hands and lather
  • apply to face, nose area and neck and gently massage into skin
  • rinse thoroughly with tepid water

Other information

  • store at 20 oC-25 oC (68 oF to 77 oF)

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Chamomilla Recutita (Matricaria) Flower Extract, Cacamidopropyl PG-Dimonium Chloride Phosphate, Propylene Glycol, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Lactate, PEG-80 Sorbitan Laurate, Disodium EDTA, Benzalkonium Chloride, Fragrance, Yellow 5, Red 40

Distributed By

GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 MADE IN CHINA

OIL-FREE ACNE WASH 236mL

Product Label

Cleanser Label

SALICYLIC ACID 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-8900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
CHAMOMILE (UNII: FGL3685T2X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-8900-0236 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/15/201711/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/15/201711/15/2017
Labeler - Greenbrier International, Inc. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
Lab Douce Cosmetics (Shenzhen) Co., Ltd.529303186manufacture(33992-8900)

Revised: 5/2018
Document Id: 6b363a12-0307-9778-e053-2a91aa0aeee7
Set id: 5f434e4b-4ba8-1686-e053-2991aa0ac526
Version: 2
Effective Time: 20180502
 
Greenbrier International, Inc.