Label: AVEENO ECZEMA THERAPY NIGHTTIME ITCH RELIEF BALM- colloidal oatmeal cream

  • NDC Code(s): 69968-0772-1, 69968-0772-2
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 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

    • • 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

    • 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

    Aveeno®

    Eczema Therapy

    NIGHTTIME ITCH RELIEF BALM

    Colloidal Oatmeal Skin Protectant Cream

    Soothes Itchy,

    Eczema-Prone Skin

    Itch relief that starts working instantly

    with intense, long lasting moisture

    STEROID FREE

    FRAGRANCE FREE

    ACCEPTED

    e

    National

    Eczema

    Association

    DERMATOLOGIST RECOMMENDED BRAND

    COLLOIDAL OATMEAL & CERAMIDE

    net wt. 11 oz (312 g)

    Aveeno_01

  • INGREDIENTS AND APPEARANCE
    AVEENO ECZEMA THERAPY NIGHTTIME ITCH RELIEF BALM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0772
    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)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    OAT (UNII: Z6J799EAJK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CERAMIDE NP (UNII: 4370DF050B)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0772-212 in 1 PACKET08/01/2022
    128 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:69968-0772-1312 g in 1 JAR; Type 0: Not a Combination Product08/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/01/2022
    Labeler - Kenvue Brands LLC (118772437)
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