BABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]

BABY DAILY MOISTURIZING FRAGRANCE FREE (DIMETHICONE) LOTION [HARMON STORES INC.]
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NDC 63940-433-12
Set ID 28b33138-2288-4e8e-aa6e-25f0dc9deffe
Category HUMAN OTC DRUG LABEL
Packager Harmon Stores Inc.
Generic Name
Product Class
Product Number
Application Number PART347
  • Active ingredient

    Dimethicone 1.2%

  • Purpose

    Skin protectant

  • Uses

    helps prevent and temporarily protects chafed, chapped and cracked skin
    helps prevent and 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
  • Other Information

    store at room temperature
  • Inactive ingredients

    water, glycerin, behentrimonium methosulfate, cetyl alcohol, butylene glycol, cetearyl alcohol, isopropyl palmitate, petrolatum, avena sativa (oat) kernel flour, distearyldimonium chloride, benzyl alcohol, allantoin, sodium chloride, triethanolamine

  • Package/Label Principal Display Panel

    buybuy
    BABY

    daily
    moisturizing
    LOTION

    with natural
    colloidal oatmeal

    dimethicone skin protectant

    Aids in the healing & protection of delicate skin

    24 hour moisturizing

    FRAGRANCE
    FREE

    NET WT 8 OZ (227 g)

    daily moisturizing
    BABY LOTION

    Enriched lotion with natural colloidal oatmeal combined with rich, soothing emollients that help heal baby’s delicate skin. This non-greasy, nourishing formula is quickly absorbed to provide long-lasting moisturization. Hypoallergenic, fragrance free, and alcohol free; this formula won’t clog pores or irritate sensitive skin and is suitable for newborns. Gentle enough to be used every day to help keep baby’s skin soft, smooth, and healthy-looking.

    MADE EXPRESSLY FOR
    buybuyBABY™
    650 LIBERTY AVENUE,
    UNION, NJ 07083
    © BUY BUY BABY INC.
    WWW.BUYBUYBABY.COM

    MADE IN ISRAEL

    4D334 B1 T1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    BABY DAILY MOISTURIZING FRAGRANCE FREE 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-433
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    OATMEAL (UNII: 8PI54V663Y)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-433-12227 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2014
    Labeler - Harmon Stores Inc. (804085293)

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