Label: AVEENO ECZEMA THERAPY DAILY MOISTURIZING- oatmeal cream

  • NDC Code(s): 69968-0421-1, 69968-0421-2, 69968-0421-5, 69968-0421-7
  • 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:

    • rashes
    • eczema
  • 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

    • 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

    Aveeno®

    Eczema

    Therapy

    DAILY MOISTURIZING

    CREAM

    Colloidal Oatmeal Skin Protectant

    Relieves

    Eczema-prone skin

    Clinically shown to soothe

    dry, itchy, irritated skin

    due to eczema

    STEROID FREE

    FRAGRANCE FREE

    DERMATOLOGIST RECOMMENDED BRAND

    COLLOIDAL OATMEAL & CERAMIDE

    ACCEPTED

    e

    NATIONAL

    ECZEMA

    ASSOCIATION

    net wt. 7.3 oz (206 g)

    Aveeno_001

  • INGREDIENTS AND APPEARANCE
    AVEENO ECZEMA THERAPY DAILY MOISTURIZING 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0421
    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:69968-0421-5141 g in 1 TUBE; Type 0: Not a Combination Product10/01/2010
    2NDC:69968-0421-7206 g in 1 TUBE; Type 0: Not a Combination Product10/01/2010
    3NDC:69968-0421-114 g in 1 TUBE; Type 0: Not a Combination Product10/01/2010
    4NDC:69968-0421-2354 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/201806/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2010
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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