XZM KIDS CARE (COLLOIDAL OATMEAL) CREAM [LAVIOR INC]

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XZM KIDS CARE (COLLOIDAL OATMEAL) CREAM [LAVIOR INC]
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NDC 71521-407-30
Set ID 85901bc6-5eb1-66cd-e053-2a91aa0a5e45
Category HUMAN OTC DRUG LABEL
Packager Lavior Inc
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Colloidal Oatmeal 1% ............... Skin Protectant

  • Purpose

    Skin protectant

  • Uses

    temporarily protects and helps relieve minor skin irritation and itching due to:
    rashes
    eczema

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes

    Stop use and ask a doctor if

    condition worsens
    symptoms last more than 7 days or clear up and occur again within a few days

  • Keep out of reach of children

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

  • Directions

    Apply a thin layer 1 to 2 times daily, or as directed by a doctor
    For babies under 2 months of age: ask a doctor

  • Other information

    For mild to moderate eczema.
    Store at room temperature.

  • Inactive ingredients

    Aqua, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Glyceryl Stearate Citrate, Aloe Barbadensis Leaf Juice, Propanediol-1,3, Cetyl Alcohol, Sodium Benzoate, Potassium Sorbate, Biosaccharide Gum-1, Tocopheryl Acetate (Vitamin E), Sodium Gluconate, Citric Acid.

  • Questions?

    Call toll free 1-844-474-2552 or visit lavior.com

  • PRINCIPAL DISPLAY PANEL

    XZM Kids Label

  • INGREDIENTS AND APPEARANCE
    XZM KIDS CARE 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71521-407
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71521-407-301 in 1 BOX04/02/2019
    130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/02/2019
    Labeler - Lavior Inc (080685327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lavior Inc.080685327manufacture(71521-407)
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