Label: BABY XTRACARE OATMEAL- dimethicone lotion

  • NDC Code(s): 58503-070-01, 58503-070-02
  • Packager: China Ningbo Shangge Cosmetic Technology Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 13, 2019

If you are a consumer or patient please visit this version.

  • 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)