ACNE SCRUB (salicylic acid) gel

ACNE SCRUB (salicylic acid) gel by

Drug Labeling and Warnings

ACNE SCRUB (salicylic acid) gel by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., Lab Douce Cosmetics (Shenzhen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACNE SCRUB (SALICYLIC ACID) GEL- acne scrub (salicylic acid) gel 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 SCRUB (salicylic acid) gel

Drug Facts


Active Ingredients

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

Purpose

Acne Treatment

Uses

  • For the treatment of acne

Warnings

For external use only

For adult use only

When using this product

and other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Stop Use and ask a doctor if irritation and redness develop.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Directions

  • cleanse twice a day
  • wet face. Apply to hands, add water and work into a lather
  • massage face gently
  • rinse thoroughly with water

Other information

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

Inactive Ingredients

water, sodium laureth sulfate, acrylates/steareth-20 methacrylate copolymer, cocamide MEA, zeolite, sodium hydroxide, acrylates/c10-30 alkyl acrylate crosspolymer, fragrance, methylisothiazolinone, red 40, yellow 5

Distributed By

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

Foaming Acne Scrub 119g

Product Label

Cleanser Label

ACNE SCRUB (SALICYLIC ACID) GEL 
acne scrub (salicylic acid) gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 33992-8905
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
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
LAURIC MONOETHANOLAMIDE (UNII: 098P2IGT76)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 33992-8905-0119 g in 1 TUBE; Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/01/201812/31/2019
Labeler - Greenbrier International, Inc. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
Lab Douce Cosmetics (Shenzhen) Co., Ltd.529303186manufacture(33992-8905)

Revised: 12/2019
Document Id: 9a980a76-cf57-b86f-e053-2a95a90af5a6
Set id: 7349bc17-9bd3-90b2-e053-2a91aa0a5604
Version: 2
Effective Time: 20191226
 
Greenbrier International, Inc.