Label: UREA 20- urea gel

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

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Drug Label Information

Updated March 6, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient: UREA 20%

  • PURPOSE

    Purpose: Moisturizer

  • INDICATIONS & USAGE

    Usage: Soothes, Softens and Moisturizes Dry Rough Skin.

  • WARNINGS SECTION

    Caution: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. For External Use Only.

  • DO NOT USE

    Do not use: Do not use if safety seal on the tube is broken or missing. For lot number and exp. date, see crimp of tube or carton.

  • WHEN USING

    Directions: Apply to desired areas of the hands, feet, knees, or elbows twice daily, or as directed by a physician. Rub into the skin until fully absorbed. Do not use on tender skin areas such as the face, neck, or scalp.

  • STOP USE

    Stop use: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.

  • DOSAGE & ADMINISTRATION

  • INACTIVE INGREDIENT

    Inactive Ingredients: Cetyl Alcohol, Carbomer, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, Stearyl Alcohol, Triacetin, White Petrolatum.

  • STORAGE AND HANDLING

    Storage: Store at 20°C (68°F - 77°F), excursions permitted between 15°C and 30°C (59°F - 86°F). Protect from Freezing. Store in a cool dry place. [See USP Controlled Room Temperature]

  • QUESTIONS

    Questions or comments? 1-855-361-3993

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    UREA 20% Cream

    FOR EXTERNAL USE ONLY.

    Soothes, Softens and Moisturizes Dry Rough Skin

    AvKARE

    NET WT. 3 OZ. (85 g)


    Manufactured for: AvKARE,
    Pulaski, TN 38478
    www.avkare.com
    Questions or comments? 1-855-361-3993 AV 04/22

    Carton

    UREA 20% Cream

    Product No. 50268-820-85

    FOR EXTERNAL USE ONLY.

    Soothes, Softens and Moisturizes Dry Rough Skin

    AvKARE

    NET WT. 3 OZ. (85 g)

    tube
  • INGREDIENTS AND APPEARANCE
    UREA 20 
    urea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-820
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TRIACETIN (UNII: XHX3C3X673)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Product Characteristics
    Colorwhite (Opaque White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-820-851 in 1 CARTON09/19/2022
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/19/2022
    Labeler - AvPAK (832926666)
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