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 1, 2015

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  • claims

    Oatmeal

    Lotion

  • Active ingredient

    Dimethicone 1.3%

  • Purpose

    Skin protectant

  • use

    • helps prevent and temporarily protects chafed, chapped, or cracked skin
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • 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
  • Do not use on 

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply as necessary

  • Inactive ingredients

    Avena sative (oat) kernel flour, benzyl alcohol, cetyl alcohol, distearyldimonium chloride, glycerin, isopropyl palmitate, petrolatum, sodium chloride, water

  • Disclaimer

    This product is not manufactured or distributed by Johnson & Johnson Consumer Prodcuts Company, distributor of Aveeno Active Naturals Daily Moisturizing Lotion

  • Adverse Reactions

    DISTRIBUTED BY: SAVE-A-LOT FOOD STORES, LTD

    EARTH CITY, MO 63045    savealot.com

  • Principal Display Panel

    COMPARE TO

    AVEENO

    ACTIVE NATURALS

    DAILY MOISTURIZING

    LOTION

    DAILY

    MOISTURIZING

    Oatmeal

    Lotion

    SKIN PROTECTANT

    • Relieves and Protects Dry Skin
    • Non-comedogenic
    • Fragrance Free

    DERMATOLOGIST

    TESTED

    BEING WELL

    12 FL OZ (354 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    OATMEAL 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46994-619
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OATMEAL (UNII: 8PI54V663Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46994-619-32354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/20/2015
    Labeler - Save A Lot Food Stores LTD (095484572)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture(46994-619)
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