Label: AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM- oatmeal cream

  • NDC Code(s): 69968-0540-1, 69968-0540-2, 69968-0540-5
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 4, 2025

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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:
    Kenvue Brands LLC
    Summit, NJ 07901

  • PRINCIPAL DISPLAY PANEL - 28 g Jar Label

    Recommended by

    Pediatricians & Dermatologists

    Aveeno®

    baby

    NET WT. 1 OZ (28 g)

    eczema
    therapy

    nighttime balm

    colloidal oatmeal skin
    protectant + ceramide

    clinically proven to

    relieve itchy, dry, irritated

    skin due to eczema

    ACCEPTED

    e

    NATIONALECZEMA.ORG

    NATIONAL

    ECZEMA

    ASSOCIATION

    Aveeno_1

  • INGREDIENTS AND APPEARANCE
    AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0540
    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:69968-0540-228 g in 1 JAR; Type 0: Not a Combination Product03/25/2019
    2NDC:69968-0540-5156 g in 1 JAR; Type 0: Not a Combination Product03/25/2019
    3NDC:69968-0540-1312 g in 1 JAR; Type 0: Not a Combination Product03/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/25/2019
    Labeler - Kenvue Brands LLC (118772437)
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