NDC 69492-014

KERACTIL Plus

Antifungal

KERACTIL Plus is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Polimeros Y Servicios S.a.. The primary component is Tolnaftate.

Product ID69492-014_f897feb9-a60e-4bb3-acd0-353f010578a3
NDC69492-014
Product TypeHuman Otc Drug
Proprietary NameKERACTIL Plus
Generic NameAntifungal
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2016-03-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NamePOLIMEROS Y SERVICIOS S.A.
Substance NameTOLNAFTATE
Active Ingredient Strength10 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69492-014-06

1 TUBE in 1 BOX (69492-014-06) > 10 g in 1 TUBE
Marketing Start Date2019-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69492-014-06 [69492001406]

KERACTIL Plus GEL
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-03-04

Drug Details

Active Ingredients

IngredientStrength
TOLNAFTATE10 mg/g

OpenFDA Data

SPL SET ID:0605381a-83cf-401d-86cf-a6a41b15355e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313420
  • NDC Crossover Matching brand name "KERACTIL Plus" or generic name "Antifungal"

    NDCBrand NameGeneric Name
    50382-004AntifungalAntifungal
    68001-475Antifungal Creamantifungal
    68001-478Antifungal Creamantifungal
    68001-481Antifungal Creamantifungal
    77338-165Astonea Miconazole nitrateAntifungal
    61767-231Blossom Pharmaceuticals Antifungalantifungal
    67777-231Dynarex Antifungalantifungal
    69492-014KERACTILANTIFUNGAL
    50382-050MICONAZOLEantifungal
    55681-165Miconazole nitrateAntifungal
    68599-1471Miconazole NitrateAntifungal

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.