Label: BABY DAILY MOISTURIZING FRAGRANCE FREE- 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 September 5, 2014

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  • 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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