Label: AVEENO ECZEMA THERAPY RESCUE RELIEF TREATMENT- colloidal oatmeal cream

  • NDC Code(s): 69968-0802-1, 69968-0802-2, 69968-0802-5, 69968-0802-9
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Colloidal Oatmeal 2%

  • 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

    • Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
  • Inactive Ingredients

    Water, Glycerin, Isopropyl Palmitate, Butyrospermum Parkii (Shea) Butter, Isododecane, Vegetable Oil, Cetyl Alcohol, Sodium Hydroxide, Lactic Acid, Sodium Polyacrylate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil, Cetearyl Olivate, Carbomer, 1,2-Hexanediol, Sorbitan Olivate, Hydrogenated Vegetable Oil, Euphorbia Cerifera (Candelilla) Wax, Avena Sativa (Oat) Kernel Extract, Tropolone

  • 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 - 150mL Bottle Label

    NEW!

    Aveeno®

    Eczema

    Therapy

    RESCUE RELIEF

    TREATMENT

    GEL CREAM

    Colloidal Oatmeal Skin Protectant

    Instantly soothes & cools

    itchy, dry skin flare-ups

    Clinically proven soothing relief

    of itch, irritation, & dry skin

    Developed with Eczema Consumers

    STEROID & FRAGRANCE FREE

    DERMATOLOGIST RECOMMENDED BRAND

    2% COLLOIDAL OATMEAL AND SHEA BUTTER

    5 fl oz (150mL)

    Aveeno_1

  • INGREDIENTS AND APPEARANCE
    AVEENO ECZEMA THERAPY RESCUE RELIEF TREATMENT 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0802
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROPOLONE (UNII: 7L6DL16P1T)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISODODECANE (UNII: A8289P68Y2)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    OAT (UNII: Z6J799EAJK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0802-244 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/05/2022
    2NDC:69968-0802-5150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/05/2022
    3NDC:69968-0802-114 mL in 1 TUBE; Type 0: Not a Combination Product09/05/2022
    4NDC:69968-0802-912 in 1 CARTON09/05/2022
    414 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/05/2022
    Labeler - Kenvue Brands LLC (118772437)
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