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 May 15, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Hydrocortisone USP 1%

  • Purpose

    Anti-itch

  • Uses

    • for temporary relief of itching associated with minor skin irritations and rashes due to: • Eczema • Insect bites • Soaps and detergents  • Cosmetics • Jewelry • Seborrheic dermatitis • Psoriasis • Poison ivy, oak or sumac • 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 • In children under 2 years of age • If you have a vaginal discharge • For the treatment of diaper rash

    Ask a doctor before use if you have • External genital or feminine itching • External anal itching • Bleeding

    When using this product • Avoid contact with eyes • Do not exceed the recommended daily dosage unless directed by a doctor • Do not put this product into the rectum by using fingers or any mechanical device or applicator

    Stop use 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, stop use and do not begin use of any other hydrocortisone product, unless you have consulted a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    For minor skin irritations and rashes, adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. 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 soft cloth before application of this product • Children: under 12 years of age, consult a doctor.

  • Inactive ingredients

    Cetostearyl Alcohol, Cetomacrogol 1000, Paraffin Wax, Micro Crystalline Wax, Propylene Glycol, Light Liquid Paraffin, Mono basic Sodium Phosphate, Propyl Paraben, Methyl Paraben, Chlorocresol, Purified Water

  • Other information

    • Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

    • store at room temperature • See crimp of tube or carton for Lot Number and Expiration Date

  • Questions or comments?

    1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

  • SPL UNCLASSIFIED SECTION

    MAXIMUM STRENGTH ANTI-ITCH CREAM

    Temporary Relief the Discomfort of itching, Rashes and Irritation on Skin Due to Eczema, Psoriasis and Insect bites

    Compared to the active ingredient in Cortizone 10

    Distributed by.

    ARU PHARMA INC.

    MOUNT VERNON, NY 10552

    www.qpackrx.com

  • Packaging

    Hydrocroz1

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE MAXIMUM STRENGTH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-923
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70403-923-301 in 1 CARTON01/01/201803/31/2025
    130 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 finalpart34801/01/201803/31/2025
    Labeler - Aru Pharma Inc. (079736192)