Label: GEHWOL MED CALLUS- urea cream

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

Drug Label Information

Updated 02/13

If you are a consumer or patient please visit this version.

  • 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 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)
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