Label: AVEENO BABY CALMING COMFORT BATH PLUS SET- dimethicone kit

  • NDC Code(s): 69968-0631-9, 69968-0656-8
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 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

    • To open, twist off cap and remove quality seal. Do not use if seal is broken.
    • Store at room temperature.
  • 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 www.aveeno.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - Kit Packet

    Aveeno ®
    baby
    calming comfort ®
    bath + lotion set

    18 FL OZ (532 mL)

    NET WT. 8 OZ (227 g)

    PRINCIPAL DISPLAY PANEL - Kit Packet
  • INGREDIENTS AND APPEARANCE
    AVEENO BABY CALMING COMFORT BATH PLUS SET 
    dimethicone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0631
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0631-91 in 1 PACKET08/03/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 227 g
    Part 21 BOTTLE 532 mL
    Part 1 of 2
    AVEENO BABY CALMING COMFORT 
    dimethicone lotion
    Product Information
    Item Code (Source)NDC:69968-0656
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0656-8227 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/01/2020
    Part 2 of 2
    AVEENO BABY CALMING COMFORT BATH 
    baby shampoos [baby products] solution
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRGLYCERYL OLEATE (UNII: 4PC054V79P)  
    INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGROAT (UNII: Z6J799EAJK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1532 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/03/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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