KERACTIL PLUS- antifungal 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 KERACTIL Plus Topical Antifungal Gel

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KERACTIL  PLUS
antifungal gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69492-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ORTHOSILICIC ACID (UNII: 623B93YABH)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69492-014-061 in 1 BOX03/04/2019
110 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/09/2016
Labeler - POLIMEROS Y SERVICIOS S.A. (815740251)
Establishment
NameAddressID/FEIBusiness Operations
POLIMEROS Y SERVICIOS S.A.815740251manufacture(69492-014)

Revised: 3/2019
Document Id: f897feb9-a60e-4bb3-acd0-353f010578a3
Set id: 0605381a-83cf-401d-86cf-a6a41b15355e
Version: 2
Effective Time: 20190305
 
POLIMEROS Y SERVICIOS S.A.