Label: GEHWOL FUSSKRAFT CALLUS SOFTENER - urea liquid 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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  • Gehwol FUSSKRAFT Callus Softener
  • Active Ingredient

    Urea 25%

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  • Purpose

    Keratolityc

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  • Uses

    • Soften nuisance callus
    • Soften the cuticles
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  • 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

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  • PRECAUTIONS

    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.

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  • Pregnancy

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

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  • 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.

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  • Other Information

    Store at 20-25° C (68°-77° F)

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  • Inactive Ingredients

    Aqua, Triethyl Citrate, Sodium Lactate, Cocamidopropyl Betaine, Lactic Acid,Sodium Chloride, Phenoxyethanol,Dehydroacetic Acid, Benzoic Acid, Sorbic Acid.

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  • Gehwol FUSSKRAFT Callus Softener

    E.Gerlach GmbH

    Baeckerstrasse 4-8

    D- 32312 Lubbecke

    Germany

    image description

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  • INGREDIENTS AND APPEARANCE
    GEHWOL FUSSKRAFT CALLUS SOFTENER 
    urea liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45264-010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    urea (urea) urea 250 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Triethyl Citrate  
    Sodium Lactate  
    Cocamidopropyl Betaine  
    Lactic Acid  
    Sodium Chloride  
    Phenoxyethanol  
    Dehydroacetic Acid  
    Benzoic Acid  
    Sorbic Acid  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45264-010-10 500 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/24/2008
    Labeler - Eduard Gerlach GmbH (315343350)
    Registrant - Eduard Gerlach GmbH (315343350)
    Establishment
    Name Address ID/FEI Business Operations
    Eduard Gerlach GmbH 315343350 manufacture(45264-010)
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