Label: HYDROCORTISONE PLUS 12 MOISTURIZERS- hydrocortisone cream

  • NDC Code(s): 11822-2090-2, 11822-2090-3
  • Packager: RITE AID CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 15, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
    • temporarily relieves external anal and genital itching
    • other uses of this product should only be under the advice 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 a doctor.

    When using this product

    • avoid contact with eyes
    • do not use more than directed unless told to do so 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
    • rectal bleeding occurs

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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: ask a doctor
    • for external anal and genital itching, adults:
      • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
      • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
      • apply to affected area not more than 3 to 4 times daily
      • children under 12 years of age: ask a doctor
  • Other information

    • to open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
    • store at 20° to 25° C (68° to 77° F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    aloe powder, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile oil, citric acid, corn oil, glycerin, glyceryl monostearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin wax, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A & vitamin D3 liquid, vitamin E, white petrolatum.

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319
    www.riteaid.com

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL - 56.8 Tube Carton

    MAXIMUM STRENGTH

    HYDROCORTISONE CREAM 1%

    PLUS 12 MOISTURIZERS

    ANTI-ITCH

    RELIEVES ITCH FAST

    For skin irritations

    • Enriched with vitamins A, D3 & Vitamin E

    NET WT 1 OZ (28.4 hydrocortisone-01 g)

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE  PLUS 12 MOISTURIZERS
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2090
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-2090-21 in 1 CARTON07/21/2023
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11822-2090-31 in 1 CARTON07/21/2023
    256.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/21/2023
    Labeler - RITE AID CORPORATION (014578892)
    Registrant - TARO PHARMACEUTICALS U.S.A., INC. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(11822-2090)
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