Label: AVEENO BABY CALMING COMFORT- dimethicone lotion

  • NDC Code(s): 69968-0629-1, 69968-0629-8
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dimethicone 1.2%

  • Purpose

    Skin protectant

  • Uses

    • Temporarily protects and helps relieve chafed, chapped, or 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.
    • Remove quality seal. Do not use if quality seal is broken.
  • Inactive ingredients

    Water , Glycerin, Distearyldimonium Chloride ,Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Fragrance, Sodium Chloride

  • Questions?

    866-428-3366; Outside US, dial collect 215-273-8755 visit www.aveeno.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON
    CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label

    RECOMMENDED BY
    PEDIATRICIANS
    & DERMATOLOGIST
    Aveeno ®
    New
    Look

    baby
    New Gentle
    Fragrance
    calming comfort ®
    lotion
    natural oatmeal
    + lavender scent
    dimethicone skin protectant
    moisturizes baby's
    skin for 24hrs
    helps calm baby
    before bedtime
    lavender &
    vanilla scented
    18 FL OZ (532 mL)

    PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    AVEENO BABY CALMING COMFORT 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0629
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 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:69968-0629-1532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
    2NDC:69968-0629-8227 mL in 1 TUBE; Type 0: Not a Combination Product06/01/202006/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/01/2020
    Labeler - Kenvue Brands LLC (118772437)
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