OATMEAL (DIMETHICONE) LOTION [GREENBRIER INTERNATIONAL]

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OATMEAL (DIMETHICONE) LOTION [GREENBRIER INTERNATIONAL]
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NDC 33992-1129-1
Set ID 42fd9acd-2922-4b84-abcb-446498f5e6f0
Category HUMAN OTC DRUG LABEL
Packager GREENBRIER INTERNATIONAL
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT


    Active Ingredient                                          Purpose

    Dimethicone 0.15%                                      Skin Protectant


  • PURPOSE


    Help prevent and temporarily protects chafed, chapped or cracked skin.
    Helps prevent and protect from the drying effects of wind and cold weather.
  • KEEP OUT OF REACH OF CHILDREN



    If swallowed, get medical help or contact a Poison Control Center right away.
  • INDICATIONS & USAGE

    Apply as needed, and do not get into eyes.

  • WARNINGS

    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

    apply as needed

  • INACTIVE INGREDIENT

    water, mineral oil, cetyl alcohol, glycerin, propylene glycol, methylparaben, propylparaben, DMDM hydantoin, steareth-30, ammonium polyacrylate,  C13-16 isoparaffin, glyceryl stearate, fragrance, avena sativa (oat) protein extract

  • PRINCIPAL DISPLAY PANEL

    image of OTC
  • INGREDIENTS AND APPEARANCE
    OATMEAL 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O) dimethicone0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    mineral oil (UNII: T5L8T28FGP)  
    cetyl alcohol (UNII: 936JST6JCN)  
    petrolatum (UNII: 4T6H12BN9U)  
    glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    dmdm hydantoin (UNII: BYR0546TOW)  
    propylparaben (UNII: Z8IX2SC1OH)  
    methylparaben (UNII: A2I8C7HI9T)  
    steareth-30 (UNII: 5776GCL1DG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1129-1340.2 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/06/2011
    Labeler - GREENBRIER INTERNATIONAL (610322518)
    Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265manufacture
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