Label: OATMEAL- dimethicone lotion

  • NDC Code(s): 76176-063-01
  • Packager: NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD
  • 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 October 24, 2022

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  • oatmeal and cream

    Oatmeal and Cream Lotion provides temporary relief for dry skin. It moisturize and prevents drying skin. Use daily for a naturally smooth and healthy looking skin. This naturally nourishing, non-greasy formula absorbs quickly and won't clog pores.

  • Active Ingredient

    Dimethicone 1%

  • Purpose

    Skin Protectant

  • Uses:

    Helps prevent and protect from the drying effects of wind and cold weather.

  • Directions:

    Apply daily or as needed

  • Warning:

    For external use only. Do not use on deep puntured wounds, animal bites or serious burns.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • STOP USE

    Stop use and ask doctor if conditions worsens. Symptons last more than 7 days or clear up and occur again.

  • Inactive Ingredients:

    Water (Aqua), Mineral Oil, Getearyl Alcohol, Glycerin, Glyceryl Stearate, Petrolatum, Ceteareth-20, Propylene Glycol, Carbomer, Triethanolamine, Avena Stiva (OAT) Kernel Flour, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, DMDM Hydantoin, Dichlorobenzyl Alcohol, Iodopropynyl Butylcarbamate, FD&C Yellow No.5, FD&C Red No. 40.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    OATMEAL 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    CETEARETH-22 (UNII: 28VZG1E234)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-063-01354 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2019
    Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD (530766098)
    Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD530766098manufacture(76176-063)
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