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

  • NDC Code(s): 69968-0772-1, 69968-0772-2
  • 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 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

    • • 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 finalM01608/01/2022
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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