Label: AVEENO BABY CALMING COMFORT- dimethicone lotion

  • NDC Code(s): 69968-0629-1, 69968-0629-8
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 January 6, 2023

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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 finalpart34706/01/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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