BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]

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BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]
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NDC 58503-070-01, 58503-070-02
Set ID cb357bc3-f7f4-406d-b124-45f8f7377bb6
Category HUMAN OTC DRUG LABEL
Packager China Ningbo Shangge Cosmetic Technology Corp
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active Ingredient                                      Purpose

    Dimethicone 1.2% ............................ Skin Protectant

  • PURPOSE

    Use

    Help prevent and temporarily protects chafed, chapped, or cracked skin.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Baby XtraCare®

    Oatmeal Daily Moisturizing Lotion

    Lightly Scented

    Dimethicon Skin Protectant with Natural Oat Extract

    Helps Soothe & Soften Baby's Skin

    12 FL OZ (354 mL)

  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally as often as needed.

  • WARNINGS

    Warnings

    For extenal use only.

    When using this product avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if condition worsens. Symptoms last more than 7days or clear up and occur again within a few days.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, petrolatum, mineral oil, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oatmeal) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben.

  • OTHER SAFETY INFORMATION

    Other Information  S tore at room temperature.

    Questions/Comments? 1-855-345-5575

    DISTRIBUTED BY

    REJOICE INTERNATIONAL INC

    NORTHVILLE, MI 48168 U.S.A.

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    8oz label image

    12oz label image

  • INGREDIENTS AND APPEARANCE
    BABY XTRACARE OATMEAL 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-070-01227 g in 1 BOTTLE; Type 0: Not a Combination Product02/16/2015
    2NDC:58503-070-02354 g in 1 BOTTLE; Type 0: Not a Combination Product02/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/16/2015
    Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(58503-070)
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