Label: TOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS- hydrocortisone cream

  • NDC Code(s): 36800-051-06, 36800-051-18
  • Packager: Topco Associates LLC
  • 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 April 1, 2019

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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 barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

  • Questions?

    Call 1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    NDC 36800-051-18

    TopCare
    health™

    MAXIMUM STRENGTH

    • OUR PHARMACISTS
    RECOMMEND •

    Hydrocortisone Cream 1%

    ANTIPRURITIC (ANTI-ITCH)

    Plus 12 Moisturizers

    NET WT 1 OZ (28.4 g)

    Principal Display Panel - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOPCARE   HYDROCORTISONE PLUS 12 MOISTURIZERS
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-051
    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:36800-051-181 in 1 CARTON10/03/1989
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:36800-051-061 in 1 CARTON10/03/1989
    242.6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/03/1989
    Labeler - Topco Associates LLC (006935977)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-051)
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