Label: GEHWOL MED CALLUS- urea cream

  • 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

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

  • Gehwol med Callus Cream
  • Active Ingredients

    Urea 18%

    Close
  • Purpose

    Keratolytic

    Close
  • Uses

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

    Close
  • 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

    Close
  • Pregnancy

    If pregnant or breast feeding ask a health professional before use

    Close
  • Directions

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

    Close
  • Other Information

    Store at 20-25° C (68°-77° F)

    Close
  • 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

    Close
  • Gehwol med Callus Cream

    Immediately softens and noticeably reduces callus within a few days.

    image description

    Net WT. 2.6 oz 75 ml

    Close
  • INGREDIENTS AND APPEARANCE
    GEHWOL MED CALLUS 
    urea cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45264-006
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Urea (Urea) Urea 180 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    AVOCADO OIL  
    GLYCERIN  
    POLYGLYCERIN-3  
    ISOPROPYL PALMITATE  
    OCTYLDODECANOL  
    GLYCERYL STEARATE SE  
    CETYL ALCOHOL  
    PPG-3 BENZYL ETHER MYRISTATE  
    MYRISTYL MYRISTATE  
    SILK, BASE HYDROLYZED (1000 MW)  
    TRIETHYL CITRATE  
    PHENOXYETHANOL  
    METHYLPARABEN  
    ETHYLPARABEN  
    CAPRYLYL GLYCOL  
    ALLANTOIN  
    XANTHAN GUM  
    FARNESOL  
    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)
    Close