Label: HYDROCORTISONE WITH ALOE- hydrocortisone cream

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

Drug Label Information

Updated February 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch cream

  • Uses

    •
    temporary relief of itching associated with minor skin irritations and rashes due to
    o
    eczema
    o
    insect bites
    o
    poison ivy, poison oak, or poison sumac
    o
    soaps
    o
    detergents
    o
    cosmetics
    o
    jewelry
    o
    seborrheic dermatitis
    o
    psoriasis
    o
    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

    Do not use

    •
    in the eyes
    •
    by putting this product into the rectum by using fingers or any mechanical device or applicator

    Ask a doctor before use if you have

    •
    a vaginal discharge
    •
    rectal bleeding
    •
    diaper rash

    When using this product consult a doctor before exceeding recommended dosage

    Stop use and ask a doctor if

    •
    condition gets worse
    •
    condition persists for more than 7 days
    •
    condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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

  • 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. consult a doctor

    For external anal itching:

    •
    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

    •
    To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
    •
    store at room temperature
    •
    see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

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

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

    Relabeled by:
    Proficient Rx LP
    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    Itch and Rash Relief

    MAXIMUM STRENGTH

    Hydrocortisone 1%
    Cream
    Antipruritic (Anti-Itch)

    With Aloe

    NET WT 1 oz (28.4 g)

    63187-504-01
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE  WITH ALOE
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-504(NDC:51672-2013)
    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 CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    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)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-504-011 in 1 CARTON02/02/2015
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/23/1995
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-504)
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