Label: CORTIZONE 10 EASY RELIEF- hydrocortisone liquid

  • 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 February 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Cortizone-10® Easy Relief Applicator

  • Active Ingredient:

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
      • eczema
      • psoriasis
      • poison ivy, oak, sumac
      • insect bites
      • detergents
      • jewelry
      • cosmetics
      • soaps
      • seborrheic dermatitis
    • other uses of this product should be only under the advice and supervision of a doctor
  • Warnings

    For external use only

    Flammable. Keep away from fire or flame.

    Do not use

    • for the treatment of diaper rash. Consult a doctor.
    • if you are allergic to any ingredient in this product

    When using this product

    • avoid contact with eyes
    • do not use more than directed unless told to do so by a doctor. 

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product unless you have asked a doctor

    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 by placing applicator on skin, press firmly and hold to activate the dispensing of liquid. Do not use more than 3 to 4 times daily.
    • children under 2 years of age: do not use, ask a doctor
  • Inactive Ingredients

    Alcohol denat. (45%), aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, hydroxyethyl cellulose, maltodextrin, menthyl lactate, methyl gluceth-20, PEG-8, , sodium citrate, water

    KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION.

    Close cap tightly after use.                   0042734-03

    *Refers to the ingredient hydrocortisone  

    CHATTEM®

    Distributed by: Chattem, Inc.
    P.O. Box 2219, Chattanooga,TN 37409-0219
    U.S.A. ©2008     www.chattem.com

  • Principal Display Panel

    MAXIMUM STRENGTH

    Cortizone●10®

    EASY RELIEFTM 

    APPLICATOR

    Targets Itch Fast!

    • Insect Bites
    • Redness & Inflammation
    • Skin Irritation & Rashes
    • No Mess

    with Healing Aloe

    1% HYDROCORTISONE ANTI-ITCH LIQUID

    1.25 fl oz (36mL) Principal Display Panel MAXIMUM STRENGTH Cortizone●10® EASY RELIEFTM APPLICATOR Targets Itch Fast! • Insect Bites • Redness & Inflammation • Skin Irritation & Rashes • No Mess with Healing Aloe 1% HYDROCORTISONE ANTI-ITCH LIQUID 1.25 fl oz (36mL)

  • INGREDIENTS AND APPEARANCE
    CORTIZONE 10 EASY RELIEF 
    hydrocortisone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OAT (UNII: Z6J799EAJK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0032-01 in 1 CARTON10/01/2008
    137 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2008
    Labeler - Chattem, Inc. (003336013)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHATTEM, INC.003336013analysis(41167-0032) , manufacture(41167-0032)
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