DAILY OATMEAL (DIMETHICONE) LOTION [DZA BRANDS, LLC]

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DAILY OATMEAL (DIMETHICONE) LOTION [DZA BRANDS, LLC]
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NDC 55316-009-32
Set ID 815f300f-25a0-49d7-b53b-39aaa5ea1fdb
Category HUMAN OTC DRUG LABEL
Packager DZA BRANDS, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • 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 needed

  • Inactive ingredients

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

  • 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: DZA BRANDS, LLC

    2110 EXECUTIVE DRIVE

    SALISBURY,NC 28147

    For product questions or concerns, contact

    us at 1-866-322-2439.  Please include UPC number and code from package

    619.003/AC

  • princpal display panel

    healthy

    accents

    daily

    oatmeal lotion

    skin protectant

    dermatologist tested

    relieves dry skin

    fragrance free

    compare to Aveeno Active Naturals Daily Moisturizing Lotion

    12 FL OZ (354 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DAILY OATMEAL 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-009
    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:55316-009-32354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/06/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/06/2015
    Labeler - DZA BRANDS, LLC (090322194)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(55316-009)
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