Label: UREA 20- urea cream

  • NDC Code(s): 83720-561-01, 83720-561-03, 83720-561-07
  • Packager: Oncor Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 10, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient:UREA 20%

  • PURPOSE

    Intensive Hydrating Cream:

    • Moisturizes to help relieve rough, cracked skin caused by dryness.
    • Helps to restore skin's natural moisture barrier.
  • INACTIVE INGREDIENT

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

  • INDICATIONS & USAGE

    Usage: Deeply Moisturizes Skin.

  • WARNINGS SECTION

    Caution:Do not use on tender skin areas such as the face, neck, or scalp. Do not apply to broken skin, If redness occurs, discontinue use. Avoid contact with eyes.

  • DO NOT USE

    Do not use if safety seal on the tube is broken or missing.

  • DOSAGE & ADMINISTRATION

  • STORAGE AND HANDLING

    Storage: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing and avoid excessive heat.

  • 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.

  • QUESTIONS

    You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST),
    at 1-443-876-7900 or FDA at 1-800-FDA-1088.

  • KEEP OUT OF REACH OF CHILDREN

    CAUTION : USE ONLY AS DIRECTED. FOR EXTERNAL USE ONLY.
    KEEP OUT OF REACH OF CHILDREN.

  • SPL UNCLASSIFIED SECTION

    Manufactured In USA For:

    ONCOR PHARMACEUTICALS
    8815 Center Park Dr Suite 430
    Columbia
    Maryland 21045

    Rev. 05/24

  • PRINCIPAL DISPLAY PANEL

    ONCOR PHARMACEUTICALS

    NDC 83720-561-03

    UREA 20%

    Intensive Hydrating Cream

    Deeply Moisturizes Skin

    For external use only

    NET WT. 3 OZ. (85 g)

    CARTON

    ONCOR PHARMACEUTICALS

    NDC 83720-561-03

    UREA 20% Cream

    Intensive Hydrating Cream

    Deeply Moisturizes Skin

    For external use only

    NET WT. 3 OZ. (85 g)

    TUBE

  • INGREDIENTS AND APPEARANCE
    UREA 20 
    urea cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83720-561
    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:83720-561-031 in 1 CARTON05/10/2024
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:83720-561-011 in 1 CARTON05/10/2024
    228.3 g in 1 CARTON; Type 0: Not a Combination Product
    3NDC:83720-561-071 in 1 CARTON05/10/2024
    3198.4 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/10/2024
    Labeler - Oncor Pharmaceuticals (119032580)
    Registrant - Oncor Pharmaceuticals (119032580)
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