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.

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Gehwol med Callus Cream

Active Ingredients

Urea 18%

Purpose

Keratolytic

Uses

  • Remove nuisance callus in 28 days
  • Provide moisture and smoothes the skin

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:45264-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea180 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45264-006-271 in 1 BOX07/08/201004/12/2017
175 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/08/201004/12/2017
Labeler - Eduard Gerlach GmbH (315343350)
Registrant - Eduard Gerlach GmbH (315343350)
Establishment
NameAddressID/FEIBusiness Operations
Eduard Gerlach GmbH315343350manufacture(45264-006)

Revised: 4/2017
Document Id: e8b96d81-4f4e-44c4-80a0-ac7b75dd50cd
Set id: c91aa19a-1a04-4dd6-ab03-bd59824c1118
Version: 3
Effective Time: 20170412
 
Eduard Gerlach GmbH