Your browser does not support JavaScript! GEHWOL FUSSKRAFT CALLUS SOFTENER (UREA) LIQUID [EDUARD GERLACH GMBH]
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GEHWOL FUSSKRAFT CALLUS SOFTENER (urea) liquid
[Eduard Gerlach GmbH]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

Gehwol FUSSKRAFT Callus Softener

Active Ingredient

Urea 25%

Purpose

Keratolityc

Uses

  • Soften nuisance callus
  • Soften the cuticles

Warnings

  • For professional use only
  • For external use only

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.

Pregnancy

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

Directions

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

Germany

image description

GEHWOL FUSSKRAFT CALLUS SOFTENER 
urea liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45264-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
urea (urea) urea250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Triethyl Citrate 
Sodium Lactate 
Cocamidopropyl Betaine 
Lactic Acid 
Sodium Chloride 
Phenoxyethanol 
Dehydroacetic Acid 
Benzoic Acid 
Sorbic Acid 
Packaging
#Item CodePackage Description
1NDC:45264-010-10500 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/24/2008
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Establishment
NameAddressID/FEIBusiness Operations
Eduard Gerlach GmbH315343350manufacture(45264-010)

Revised: 02/2013
Document Id: 47f911ea-2fd5-4b39-96c7-66fd9218f3a2
Set id: 2167f0c5-8c3e-4440-b99c-1470521c7c8c
Version: 2
Effective Time: 20130214
 
Eduard Gerlach GmbH

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