GEHWOL MED CALLUS- urea cream 
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 med Callus Cream

Active Ingredients

Urea 18%

Purpose

Keratolytic

Uses

Warnings

For External use only.

When using this product

avoid contact with eyes and mucous mebranes. Do not apply on cracked, sensitive or injured skin.

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

Precautions

Stop use and ask a doctor if

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

´╗┐Apply cream regularly to the affected skin areas twice a day. do not remove.

Other Information

Store at 20-25° C (68°-77° F)

Inactive Ingredients

Ingredients: Aqua (Water), Persea Gratissima (Avocado) Oil, Glycerin, Polyglyceryl-3 Methylglucose Distearate, Isopropyl Palmitate, Octyldodecanol,Glyceryl Stearate, Cetyl Alcohol, PPG-3 Benzyl Ether Myristate, Myristyl Myristate, Triethyl Citrate, Hydrolyzed Silk, Allantoin, Farnesol, Xanthan Gum, Phenoxyethanol, Methylparaben, Ethylparaben, Caprylyl Glycol, Parfum (Fragrance), Citronellol, Hexyl Cinnamal, Butylphenyl Methylpropional, Limonene, Linalool, Alpha-Isomethyl Ionone

Gehwol med Callus Cream

Immediately softens and noticeably reduces callus within a few days.

image description

Net WT. 2.6 oz 75 ml

GEHWOL MED CALLUS 
urea cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45264-006
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea 180 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALLANTOIN (UNII: 344S277G0Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FARNESOL (UNII: EB41QIU6JL)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45264-006-27 1 in 1 BOX
1 75 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/08/2010
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Establishment
Name Address ID/FEI Business Operations
Eduard Gerlach GmbH 315343350 manufacture(45264-006)

Revised: 2/2013
Document Id: b66d5f86-1e9e-45ff-9930-a73a2d8410be
Set id: c91aa19a-1a04-4dd6-ab03-bd59824c1118
Version: 2
Effective Time: 20130213
 
Eduard Gerlach GmbH