Label: AVEENO BABY ECZEMA THERAPY MOISTURIZING- oatmeal cream

  • NDC Code(s): 69968-0404-1, 69968-0404-2, 69968-0404-5, 69968-0404-7
  • 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 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal Oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to:

    • Eczema
    • Rashes
  • 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.

    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 quality seal is broken.
    • For use on mild to moderate eczema or as directed by a physician.
    • Store at room temperature.
  • Inactive ingredients

    Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Sodium Chloride, Avena Sativa (Oat) Kernel Extract

  • 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 - 206 g Tube Label

    RECOMMENDED BY
    PEDIATRICIANS
    & DERMATOLOGISTS

    Aveeno ®

    baby

    NEW
    LOOK
    Same Great
    Formula

    eczema
    therapy
    moisturizing cream

    colloidal oatmeal
    skin protectant
    + vitamin B 5
    clinically proven to
    relieve itchy, irritated
    skin due to eczema

    ACCEPTED
    e
    NATIONALECZEMA.ORG

    NATIONAL
    ECZEMA
    ASSOCIATION

    fragrance-free & steroid-free,
    hypoallergenic

    NET WT. 7.3 OZ. (206g)

    PRINCIPAL DISPLAY PANEL - 206 g Tube Label
  • INGREDIENTS AND APPEARANCE
    AVEENO BABY ECZEMA THERAPY MOISTURIZING 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0404
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    OAT (UNII: Z6J799EAJK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0404-5141 g in 1 TUBE; Type 0: Not a Combination Product06/01/2010
    2NDC:69968-0404-7206 g in 1 TUBE; Type 0: Not a Combination Product06/01/2010
    3NDC:69968-0404-114 g in 1 TUBE; Type 0: Not a Combination Product06/01/2010
    4NDC:69968-0404-2354 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/201311/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2010
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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