Label: HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 8, 2024

If you are a consumer or patient please visit this version.

  • 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, oak, 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 (1-800-222-1222) immediately.

  • Warnings

    • for external use only
    • avoid contact with eyes
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    For External Anal Itching Users:

    • do not exceed the recommended daily dosage unless directed by a doctor
    • in case of bleeding, consult a doctor promptly
    • children under 12 years of age: consult a doctor

    Before using any medication, read all label directions. Keep this carton as it contains important information

  • Do Not Use

    • For the treatment of diaper rash, consult a doctor
    • For the external genital itching if you have a vaginal discharge, consult a doctor
  • Stop using this product and ask a doctor if

    • 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.
  • 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
    • for external genital, feminine and anal itching 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

    • Do not use, consult a doctor

    For External and anal itching

    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

    by patting or blotting with toilet tissue or a soft cloth before application of this product.

    • adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
    • children under 12 years of age with external anal itching: consult a doctor.
  • 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)
  • Other Information

    Distributed By:

    Rugby Laboratories®

    Indianapolis, IN 46268

    www.majorpharmaceuticals.com

    1-800-616-2471

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

  • Package Label

    371172 Rugby Hydrocortisone Cream with Aloe 112823 CDER

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE CREAM WITH ALOE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1407
    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
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1407-951 in 1 BOX03/08/2024
    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 DrugM01703/08/2024
    Labeler - Rugby Laboratories (079246066)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)