Label: HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream

  • NDC Code(s): 70000-0662-1
  • Packager: Cardinal Health 110 dba LEADER
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 25, 2024

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  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • Uses

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

    • eczema
    • seborrheic dermatitis
    • psoriasis
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • external feminine, genital and anal itching

    Other uses of this product should be only under the advice and supervision of a doctor

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Warnings

    • for external use only
  • Stop using this product and ask a doctor

    • conditions worsen
    • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
  • Do Not Use

    For the treatment of diaper rash, consult a doctor.

    For external genital itching if you have a vaginal discharge, consult a doctor.

  • When Using this product

    • Avoid contact with the eyes.
    • Do not begin the use of any other hydrocortisone product unless you have consulted a doctor
    • Do not exceed the recommended daily dosage unless directed by a doctor.
    • In case of bleeding, stop use, consult a doctor
    • Do not put this product into the rectum by using fingers or any mechanical device or applicator

  • Directions

    Adults and children 2 years and older

    apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age, ask a doctor

    For external and anal itching

    adults, when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before applicaiton of this product.

  • Inactive Ingredients

    Aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, methylparaben, mineral oil, mono-and-di-glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate.

  • Other Information

    • store at controlled room temperature 20°-25°C (68°-77°F)
    • Tamper Evident: do not use if the seal on the tube is punctured or not visible.
  • Other Information

    Distributed By:

    CARDINAL HEALTH

    CAH Dublin, OH 43017

    www.myleader.com

    ©2023 CARDINAL HEALTH. All rights reserved CARDINAL HEALTH LOGO, ESSENTIAL TO CARE, and the LEADER LOGOs are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

    1-800-200-6313

    *This product is not manufactured or distributed by Chattem Inc. owner of the registered trademark Cortizone 10®

    CIN 5878020

  • Questions

    Call 1-888-296-9067

  • PRINCIPAL DISPLAY PANEL

    5878020 LEADER HYDROCORTISONE CREAM WITH ALOE 1OZ 022824 CDER

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE CREAM WITH ALOE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0662
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0662-11 in 1 BOX04/16/2024
    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 DrugM01704/16/2024
    Labeler - Cardinal Health 110 dba LEADER (063997360)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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