OATMEAL (DIMETHICONE) LOTION [BETTER LIVING BRANDS, LLC]

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OATMEAL (DIMETHICONE) LOTION [BETTER LIVING BRANDS, LLC]
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NDC 21130-898-32, 21130-898-44
Set ID d28c5a60-0597-424f-bf7f-08dca39b22f5
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • active ingredient

    Dimethicone 1.3%

  • Purpose

    skin protectant

  • Uses

    • 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

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

  • adverse reaction

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

    Moisturizing Lotion

    This non-greasy, fast absorbing formula relieves dryness and can be used every day for hands and body. It is non-comedogenic and contains no

    added fragrance

    DISTRIBUTED BY BETTER LIVING BRANDS LLC

    P.O. BOX 99, PLEASANTON, CA 94566-0009

    1-888-723-3929 www.betterlivingbrandsLLC.com

    619.003/619AC rev 2

  • principal display panel

    Signature

    CARE

    Quality Guaranteed

    Daily

    Moisturizing

    LOTION

    SKIN PROTECTANT

    PROTECTS & RELIEVES DRY SKIN

    COMPARE TO AVEENO DAILY MOISTURIZING LOTION

    fragrance-free

    non-comedogenic

    dermatologist tested

    12 FL OZ (354 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    OATMEAL 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-898
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    oatmeal (UNII: 8PI54V663Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-898-32354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/09/2016
    2NDC:21130-898-44532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/09/2016
    Labeler - Better Living Brands, LLC (009137209)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture(21130-898)
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