Label: XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING- dimethicone lotion

  • NDC Code(s): 57337-037-01, 57337-037-02
  • Packager: Rejoice International
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 29, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient                  Purpose

    Dimethicone 1/3% ...... Skin Protectant

  • PURPOSE

    XtraCare Skin Relief Oatmeal Daily Moisturizing Lotion

    dimethicone skin protectant

    with soothing oat essence

    To Protect & Relieve Dry Skin

    12 fl oz (354 mL)

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Use help prevent and temporarily protets chafed, chapped, or cracked skin.

  • WARNINGS

    Warnings For external 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 7 days or clear up and occur again within a few days.

  • DOSAGE & ADMINISTRATION

    Directions  apply liberally as often as needed.

  • OTHER SAFETY INFORMATION

    Other information Store at room temperature.

    DISTRIBUTED BY: 

    REJOICE INTERNATIONAL INC.

    48325 BINGHAMPTON DR.,

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • INACTIVE INGREDIENT

    Inactive Ingredients water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, methylparaben, propylparaben.

  • PRINCIPAL DISPLAY PANEL

    label image

    label 2 image

  • INGREDIENTS AND APPEARANCE
    XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 mg  in 354 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OAT (UNII: Z6J799EAJK)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-037-01354 mg in 1 BOTTLE; Type 0: Not a Combination Product11/26/2013
    2NDC:57337-037-02227 mg in 1 BOTTLE; Type 0: Not a Combination Product11/26/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/26/2013
    Labeler - Rejoice International (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(57337-037)
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