Label: DRYMATINE 20% UREA CREAM- 20% urea cream cream

  • NDC Code(s): 84844-009-01
  • Packager: Guoyu Trading Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2024

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  • Active Ingredient

    UREA 20%

  • Purpose

    Moisturizer

  • Use

    Soothes, Softens and Moisturizes Dry Rough Skin.

  • Warnings

    For External Use Only.
    Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.

  • 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

    Stop use and ask a doctor if redness occurs. Do not apply to broken skin. Avoid contact with eyes.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Stop Use

    Stop use and ask a doctor if redness occurs. Do not apply to broken skin. Avoid contact with eyes.

  • Ask Doctor

    Stop use and ask a doctor if redness occurs.

  • Keep Oot Of Reach Of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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.

  • Other information

    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]

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    DRYMATINE 20% UREA CREAM 
    20% urea cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84844-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CARBOMER (UNII: 0A5MM307FC)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84844-009-01150 g in 1 CAN; Type 0: Not a Combination Product11/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/05/2024
    Labeler - Guoyu Trading Co., Ltd. (963348600)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guoyu Trading Co., Ltd.963348600manufacture(84844-009)
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