GEHWOL MED FOOT- clotrimazole powder 
Eduard Gerlach GmbH

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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Gehwol med Foot Powder

Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • Effectively treats most athlete's foot
  • Deodorizes the feet and keeps them dry
  • Gehwol med Foot Powder with its high quality foot cares agents Tapioca Starch, Micronized Zinc Oxide, Triclosan and Bisabolol prevents foot odor and absorbs perspiration

Warnings

For external use only.

When using this product

avoid contact with the eyes.

Stop use and ask a doctor if

  • There is no improvement within 4 weeks
  • Irritation occurs

Do not use on

children under 2 years of age unless directed by a doctor.

Keep out of reach of children.

This Product should not be inhaled by infants. in case of accidental ingestion, get medical help or contact a poison control center right away

Directions

Dust your feet with GEHWOL med Powder once daily, if possible after using GEHWOL Foot Bath. For best results, sprinkle your socks with GEHWOL med Foot Powder as well.

Other information

Store between 20° to 25° C (68° to 77° F)

Inactive Ingredients

talc, tapioca starch,zinc oxide,bisabolol,menthol,triclosan,isopropyl alcohol,parfum/fragrance,aqua,maltrodextrin,dextrin,lecithin,patassium cetyl, phosphate

GEHWOL med. Foot Powder

image description

GEHWOL MED FOOT 
clotrimazole powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45264-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
LEVOMENOL (UNII: 24WE03BX2T)  
MENTHOL (UNII: L7T10EIP3A)  
TRICLOSAN (UNII: 4NM5039Y5X)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45264-003-06100 g in 1 CAN; Type 0: Not a Combination Product12/04/200804/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/04/200804/12/2017
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Establishment
NameAddressID/FEIBusiness Operations
Eduard Gerlach GmbH315343350manufacture(45264-003)

Revised: 4/2017
Document Id: 78caa5cb-b457-484d-9c86-4305ba8ff92a
Set id: 6f2569c5-8d22-4062-b662-96a4cb37b09d
Version: 3
Effective Time: 20170412
 
Eduard Gerlach GmbH