Eduard Gerlach GmbH

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.


Gehwol FUSSKRAFT Callus Softener

Active Ingredient

Urea 25%





When using this product

avoid contact with eyes and mucous menbranes

Do not apply on

cracked, sensitive or injured skin.

Cracked skin is a condition that must be cured before callus can be treated

Stop use and ask a doctor if

redness or orritation develops

Keep out of reach of children

if swallowed get medical help or contact a poison control center right away.


If pregnant or breast feeding ask a health professional before use.


Pour the fluid preparation into the attached handy 50ml foam dispenser bottle to help the formation of foam. Apply the foam directly on the affected area.

When applying to remove Callus, leave it on for 5 minutes.When using the Callus foam to remove the cuticle, leave it on for only 1or 2 minutes maximum. The cuticle can then be easily removed.

Any product remaining on the skin after treatment may be wiped off with a damp cloth.

Other Information

Store at 20-25° C (68°-77° F)

Inactive Ingredients

Aqua, Triethyl Citrate, Sodium Lactate, Cocamidopropyl Betaine, Lactic Acid,Sodium Chloride, Phenoxyethanol,Dehydroacetic Acid, Benzoic Acid, Sorbic Acid.

Gehwol FUSSKRAFT Callus Softener

E.Gerlach GmbH

Baeckerstrasse 4-8

D- 32312 Lubbecke


image description

urea liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45264-010
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
urea (UNII: 8W8T17847W) (urea - UNII:8W8T17847W) urea 250 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Triethyl Citrate (UNII: 8Z96QXD6UM)  
Sodium Lactate (UNII: TU7HW0W0QT)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Lactic Acid (UNII: 33X04XA5AT)  
Sodium Chloride (UNII: 451W47IQ8X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Dehydroacetic Acid (UNII: 2KAG279R6R)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Sorbic Acid (UNII: X045WJ989B)  
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45264-010-10 500 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/24/2008
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Name Address ID/FEI Business Operations
Eduard Gerlach GmbH 315343350 manufacture(45264-010)

Revised: 2/2013
Document Id: 47f911ea-2fd5-4b39-96c7-66fd9218f3a2
Set id: 2167f0c5-8c3e-4440-b99c-1470521c7c8c
Version: 2
Effective Time: 20130214
Eduard Gerlach GmbH