Label: 48% UREA CREAM cream

  • NDC Code(s): 84522-091-01
  • Packager: Yiwu Zhixin Trade Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 1, 2024

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  • COMPONENTS

    Salicylic acid 2%

  • PURPOSE

    wart remover

  • INDICATIONS & USAGE

    Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed

  • WARNINGS

    Forevemaluseony Avoid coniac wth eves li coniac ocus nse ihorouthly wt waier Keep out ofreach oi chidrenifvou ale preanant.nursing. otiaveanyunderving medca condion.consutyou healthcare provider before using the product

  • DOSAGE & ADMINISTRATION

    For external use only.

  • DO NOT USE

    Discontinue use if any irritation or adverse reaction occurs

  • WHEN USING

    When using this product, avoid contact with eyes. lf contact occurs, rinse thoroughly with waterDiscontinue use if any irritation or adverse reaction occurs.

  • STOP USE

    on broken or irritated scalp

  • KEEP OUT OF REACH OF CHILDREN

    If sxralowed, get medical help or contact a Poison Conirol Cenler ngiht away.

  • INACTIVE INGREDIENT

    Acrylates copolymer, Ethyl acetate

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    48% UREA CREAM 
    48% urea cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84522-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SESAME OIL (UNII: QX10HYY4QV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84522-091-0150 g in 1 BOX; Type 0: Not a Combination Product09/02/202412/31/2031
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/02/202412/31/2031
    Labeler - Yiwu Zhixin Trade Co., Ltd. (414262828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Zhixin Trade Co., Ltd.414262828manufacture(84522-091)
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