Label: HYDROCORTISONE D- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL

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 August 19, 2011

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  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch cream

  • 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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, scrapes
    • 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.

  • When using this product

    • avoid contact with the eyes
    • 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, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
    • rectal bleeding occurs
  • Do not use

    • for the treatment of diaper rash. Ask a doctor
    • in the genital area if you have vaginal discharge. Ask a doctor


  • Keep out of reach of children

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

  • Directions

    • For 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
    • Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
    • Gently dry by patting or blotting toilet tissue or a soft cloth before application of this product
    • Children under 12 years of age: for external itching consult a doctor
  • Other information

    Store between 20 and 25C (68 to 77F)
  • Inactive Ingredients

    citric acid, dodecyl-2-N N-dimethylaminopropionate hydrochloride, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide

  • Questions?

    Call 1-800-866-7391, Mon-Fri, 8:30 AM - 5:30 PM (PST)

  • PRINCIPAL DISPLAY PANEL

    image of carton and label
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE  D
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40002-003
    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
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride (UNII: 18F5YMF989)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40002-003-021 in 1 CARTON
    1NDC:40002-003-0328 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/19/2011
    Labeler - NexMed (USA), Inc. (031710528)
    Registrant - NexMed (USA), Inc. (031710528)