Label: HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream

  • NDC Code(s): 68016-909-01
  • Packager: Chain Drug Consortium, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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  • Drug Facts

  • Active ingredient

    Hydrocortisone USP, 1%

  • Purpose

    Anti-itch

  • Use

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

    For external use only

    Do not use

    • in the genital area if you have a vaginal discharge. Consult a doctor.
    • for the treatment of diaper rash. Consult

    When using this product

    • avoid contact with the eyes
    • do not use more than directed unless directed by a doctor
    • do not put directly into the rectum by using fingers or any mechanical device or applicator

    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 begin the use of any other hydrocortisone product unless directed by a doctor
    • rectal bleeding occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Direction

    • for itching of skin irritation, inflammation, and rashes
      • 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: consult a doctor
    • for external anal and genital itching
      • adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
      • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
      • apply to affected area not more than 3 to4 times daily
      • children under 12 years of age: consult a doctor
  • Other information

    • store at 15º-30ºC (59º-86ºF). Protect from freezing.
    • before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredients

    cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution*, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

    COMPARE TO THE ACTIVE INGREDIENT IN MAXIMUM STRENGTH CORTIZONE 10®†

    MAXIMUM STRENGTH

    Hydrocortisone Cream USP, 1%

    ANTI-ITCH CREAM

    Relieves

    Itches and Rashes

    NET WT. OZ (g)

    For the temporary relief of itching associated with minor skin irritations, inflammation and rashes

    †This product is not manufactured or distributed by Chattem, Inc., distributor of Maximum Strength Cortizone 10®.

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

  • Package label

    Hydrocortisone USP, 1%

    PREMIER VALUE Maximum Strength Hydrocortisone Cream 1%

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE  MAXIMUM STRENGTH
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-909
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-909-011 in 1 CARTON05/07/2021
    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 DrugM01705/07/2021
    Labeler - Chain Drug Consortium, LLC (101668460)
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