Label: AVEENO HYDROCORTISONE ANTI-ITCH- hydrocortisone cream

  • NDC Code(s): 69968-0511-1
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • Use

    For the temporary relief of itching associated with minor skin irritations and rashes due to:

    • eczema
    • insect bites
    • poison ivy, oak or sumac
    • soaps and detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • Other uses of this product should be only under the advice and supervision of doctor
  • Warnings

    For external use only.

    Do not use

    • in or near the eyes
    • for diaper rash; ask a doctor

    Ask a doctor before use if you are using any other hydrocortisone product

    Stop use and ask a doctor if

    • condition worsens or if symptoms persists for more than 7 days
    • 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

    • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age, do not use; ask a doctor.
  • 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.

  • Other information

    Protect from Excessive Heat (40°c/104°F)

  • Inactive ingredients

    Water, Cetearyl Alcohol, Glycerin, Isopropyl Myristate, Cetereath-20, Cyclopentasiloxane, Avena Sativa (Oat) Kernel flour, Cetyl Palmitate, Isostearyl Neopentanoate, Benzyl Alcohol, Dimethicone/Vinyltrimethylsiloxysilicate Crosspolymer, Potassium Lactate, PEG-40 Stearate, Methylparaben, Citric Acid, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide

  • 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 - 28 g Tube Carton

    Aveeno®

    1% Hydrocortisone

    ANTI-ITCH CREAM

    Effectively relieves itch from:

    Eczema ● Psoriasis

    Poison Ivy ● Oak ● Sumac

    Insect Bites ● Detergents ● Soaps

    Maximum Strength Formula

    Specially formulated for longer-lasting relief

    With Triple Oat, Aloe, & Vitamin E

    DERMATOLOGIST RECOMMENDED BRAND

    TRIPLE OAT

    net wt. 1 oz (28 g)

    Aveeno

  • INGREDIENTS AND APPEARANCE
    AVEENO HYDROCORTISONE ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    OATMEAL (UNII: 8PI54V663Y)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    OAT (UNII: Z6J799EAJK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0511-11 in 1 CARTON03/01/2019
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2019
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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