Label: HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream

  • 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 June 30, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone, USP 1%

  • Purpose

    Anti-itch

  • Uses

    • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
      • eczema
      • psoriasis
      • insect bites
      • poison ivy, oak, sumac
      • detergents
      • jewelry
      • cosmetics
      • soaps
      • seborrheic dermatitis
    • temporarily relieves external anal and genital 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 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 the eyes
    • do not use more than directed unless directed 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
    • do not begin the use of any other hydrocortisone product unless directed by a doctor
    • rectal bleeding occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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: consult a doctor
    • for external anal and genital 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
      • apply to affected area not more than 3 to 4 times daily
      • children under 12 years of age: consult a doctor
  • Other information

    • store at 15°-30°C (59°-86°F). Protect from freezing.
    • before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredients

    cetyl alcohol, citric acid1, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution1, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

    1
    Contains one or more of these ingredients to adjust pH
  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by: H2-Pharma, LLC
    Montgomery, AL 36117

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    NDC 61269-343-56
    †Compare to the active ingredient in
    Maximum Strength Cortaid®

    Maximum Strength
    Hydrocortisone Cream, USP 1%

    Anti-itch Cream

    For external use only
    Relieves itches and rashes
    For temporary relief of: Skin irritations, inflammation, rashes | Insect bites, eczema, psoriasis | Seborrheic dermatitis
    Poison ivy, oak, and sumac | External anal and genital itching

    Net wt. 1 oz (28 g)

    H2 pharma

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE MAXIMUM STRENGTH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61269-343
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61269-343-561 in 1 CARTON06/29/2021
    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 not finalpart34806/29/2021
    Labeler - H2-Pharma, LLC (028473634)
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