Label: AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM- oatmeal cream

  • NDC Code(s): 69968-0540-1, 69968-0540-2, 69968-0540-5
  • 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

    • 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

    Aveeno®
    baby
    NEW
    LOOK
    Same
    Great
    Formula
    eczema
    therapy

    nighttime balm

    colloidal oatmeal skin
    protectant + ceramide

    NET WT. 11 OZ (312 g)

    Recommended
    by Pediatricians &
    Dermatologists

    clinically proven to
    relieve itchy, dry,
    irritated skin due
    to eczema

    fragrance-free
    hypoallergenic
    steroid-free

    ACCEPTED
    e
    NATIONALECZEMA.ORG

    NATIONAL
    ECZEMA
    ASSOCIATION

    PRINCIPAL DISPLAY PANEL - 312 g Jar Label
  • 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 finalpart34703/25/2019
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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