Label: GEHWOL MED CALLUS- urea cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated February 13, 2013

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  • Gehwol med Callus Cream
  • Active Ingredients

    Urea 18%

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  • Purpose

    Keratolytic

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  • Uses

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

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  • 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

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  • Pregnancy

    If pregnant or breast feeding ask a health professional before use

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  • Directions

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

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  • Other Information

    Store at 20-25° C (68°-77° F)

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  • 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

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  • Gehwol med Callus Cream

    Immediately softens and noticeably reduces callus within a few days.

    image description

    Net WT. 2.6 oz 75 ml

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  • INGREDIENTS AND APPEARANCE
    GEHWOL MED CALLUS 
    urea cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:45264-006
    Route of Administration TOPICAL
    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)
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