Label: AVEENO ECZEMA THERAPY DAILY MOISTURIZING- colloidal oatmeal cream

  • NDC Code(s): 69968-0774-2
  • 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 August 29, 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 - 354 mL Bottle

    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

    ACCEPTED

    e

    National

    Eczema

    Association

    DERMATOLOGIST RECOMMENDED BRAND

    COLLOIDAL OATMEAL & CERAMIDE

    12 fl oz (354mL)

    Aveeno_01

  • INGREDIENTS AND APPEARANCE
    AVEENO ECZEMA THERAPY DAILY MOISTURIZING 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0774
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    OAT (UNII: Z6J799EAJK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0774-2354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01608/06/2022
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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