KLEARACTIL- acne topical treatment gel 
POLIMEROS Y SERVICIOS S.A.

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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Submission for Klearactil Acne Topical Treatment

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KLEARACTIL 
acne topical treatment gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69492-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID, L- (UNII: F9S9FFU82N)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ORTHOSILICIC ACID (UNII: 623B93YABH)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69492-012-201 in 1 BOX03/04/2019
1NDC:69492-012-0530 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/29/2015
Labeler - POLIMEROS Y SERVICIOS S.A. (815740251)
Establishment
NameAddressID/FEIBusiness Operations
POLIMEROS Y SERVICIOS S.A.815740251manufacture(69492-012)

Revised: 3/2019
Document Id: b869e975-c1b7-4a2a-9668-21db20366cf9
Set id: 344381e7-dd11-4cb9-ad44-7a4176345aef
Version: 4
Effective Time: 20190315
 
POLIMEROS Y SERVICIOS S.A.