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KERACTIL Plus

Dosage form: gel
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: POLIMEROS Y SERVICIOS S.A.
NDC Code: 69492-014

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.

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 
CETOSTEARYL ALCOHOL 
HYDROGEN PEROXIDE 
METHYLPARABEN 
ORTHOSILICIC ACID 
POLYOXYL 20 CETOSTEARYL ETHER 
PROPYLPARABEN 
SODIUM PHOSPHATE, DIBASIC 
WATER 
Packaging
#Item CodePackage Description
1NDC:69492-014-061 TUBE in 1 BOX
110 g in 1 TUBE
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/FEIOperations
POLIMEROS Y SERVICIOS S.A.815740251manufacture(69492-014)

Document Id: a376a113-8e4c-4105-ae7b-9254e05f9350
Set id: 0605381a-83cf-401d-86cf-a6a41b15355e
Version: 1
Effective Time: 20160309
 
POLIMEROS Y SERVICIOS S.A.

Medically reviewed on Mar 9, 2018

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