Label: OATMEAL- dimethicone lotion

  • 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 December 6, 2011

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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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