Label: AVEENO ECZEMA THERAPY ITCH RELIEF BALM- oatmeal cream

  • NDC Code(s): 69968-0419-1, 69968-0419-2
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2024

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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

    • Do not use if quality seal is broken or missing
    • Protect from excessive heat (40°C/104°F)
  • Inactive ingredients

    Glycerin, Water, Cetearyl Alcohol, Isocetyl Alcohol, Dimethicone, Cetyl Alcohol, Benzyl Alcohol, Ethylhexylglycerin, Sodium Cetearyl Sulfate, Benzoic Acid, Stearic Acid, Dipotassium Phosphate, Potassium Phosphate, p-Anisic Acid, Caprylic/Capric Triglyceride, Sodium Hydroxide, Avena Sativa (Oat) Kernel Oil, Ceramide NP, Citric Acid, 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 - 312 g Jar Label

     NEW LOOK
    SAME GREAT FORMULA
    Aveeno ®
    Eczema
    Therapy

    itch relief balm
    colloidal oatmeal • skin protectant cream

    Soothes Itchy Skin

    Immediate itch relief that
    lasts on eczema- prone skin
    Steroid-free • fragrance-free

    ACCEPTED
    e
    NATIONALECZEMA.ORG

     NATIONAL
     ECZEMA
     ASSOCIATION

    with
    COLLOIDAL
    OATMEAL
    & CERAMIDE

     net wt. 11 oz (312 g)

    Principal Display Panel - 312 g Jar Label
  • INGREDIENTS AND APPEARANCE
    AVEENO ECZEMA THERAPY ITCH RELIEF BALM 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0419
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOCETYL ALCOHOL (UNII: 1800H64066)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    OAT (UNII: Z6J799EAJK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0419-228 g in 1 JAR; Type 0: Not a Combination Product09/01/2016
    2NDC:69968-0419-1312 g in 1 JAR; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/01/2016
    Labeler - Kenvue Brands LLC (118772437)
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