Label: SUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH- hydrocortisone cream

  • NDC Code(s): 49348-521-72, 49348-521-78
  • Packager: Strategic Sourcing Services 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 November 25, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    for the 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 genital and anal itching.

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

  • Warnings

    • for external use only
    • avoid contact with the eyes

    Stop using this product and ask a doctor

    • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • before you begin using any other hydrocortisone product

    Do not use this product and ask a doctor

    • if you have a vaginal discharge
    • before treating diaper rash
    • before using on children under 2 years of age

    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
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
    • children under 12 years of age: consult a doctor

    Keep this and all drugs out of the reach of children.

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

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

  • Directions

    • 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: do not use, ask a doctor

    For External Anal Itching Users

    • adults: when practical, cleanse 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 application of this product
    • children under 12 years of age: consult a doctor
  • Other information

    • unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
    • if seal has been broken, do not use this product. Return product to the store where you bought it.
    • store at controlled room temperature 59°-86°F
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    aloe barbadensis, cetostearyl alcohol, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol

  • SPL UNCLASSIFIED SECTION

    Distributed by McKesson
    One Post Street
    San Francisco, CA 94104

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    sunmark™

    hydrocortisone cream 1%

    Antipruritic (Anti-Itch)
    MAXIMUM STRENGTH WITH ALOE

    NET WT 1 OZ (28.4 g)

    Principal Display Panel - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNMARK HYDROCORTISONE WITH ALOE   MAXIMUM STRENGTH
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-521
    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
    aloe vera leaf (UNII: ZY81Z83H0X)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    paraffin (UNII: I9O0E3H2ZE)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-521-721 in 1 CARTON05/01/2014
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49348-521-781 in 1 CARTON05/21/2014
    260 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 FINALpart34808/23/1995
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Taro Phamaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Phamaceuticals Inc.206263295MANUFACTURE(49348-521)
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