Label: HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE- hydrocortisone cream

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

Drug Label Information

Updated February 1, 2024

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  • Active Ingredient

    Hydrocortisone, USP 1%

  • Purpose

    Anti-itch

  • Uses

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

    •
    eczema
    •
    insect bites
    •
    poison ivy
    •
    poison oak
    •
    poison sumac
    •
    soaps
    •
    jewelry
    •
    detergents
    •
    cosmetics
    •
    psoriasis
    •
    seborrheic dermatitis
    •
    for external genital, feminine 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

    •
    for external feminine itching 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 the eyes
     
    do not begin the use of any other hydrocortisone product unless directed by a doctor
     
    for external anal itching:
                    o   do not use more than directed unless directed by a doctor   
                    o   do not put this product into the rectum by using fingers or any mechanical device or applicator
  • Stop use and ask a doctor if

    •
    symptoms last for more than 7 days
    •
    the condition gets worse
    •
    symptoms clear up and occur again in a few days
    •
    rectal bleeding occurs, consult doctor promptly
  • 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, 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

    Children under 12 years of age: consult a doctor

  • Other Information

    •
    Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
    •
    Before using any medication, read all label directions.  Keep carton, it contains important information.
  • Inactive Ingredients

    aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

  • Questions?

    1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

  • PRINCIPAL DISPLAY PANEL

    Maximum Strength

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320


    NDC 63187-567-01
    Hydrocortisone ● 10
    Hydrocortisone Cream, USP 1%
    antipruritic (anti-itch) cream with Aloe
    NET WT 1 OZ (28 g)
    Compare to the Active ingredient in Cortizone • 10®*
    Temporary Relief of Itching and Rashes Due to:

    ·         Insect Bites
    ·         Eczema
    ·         Soaps
    ·         Poison Ivy, Oak, Sumac
    ·         Seborrheic Dermatitis
    ·         Cosmetics
    ·         Psoriasis
    ·         Jewelry
    ·         Detergents

    03390311B1             VC110479     Rev 06/11

    63187-567-01
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE MAXIMUM STRENGTH WITH ALOE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-567(NDC:0904-7623)
    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)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-567-011 in 1 CARTON12/01/2018
    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 DrugM01704/21/200901/31/2025
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-567) , RELABEL(63187-567)
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