Label: HYDROCORTISONE- 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 March 15, 2011

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                            Purpose

    Hydrocortisone USP 10 mg            Antipruritic (anti-itch)

  • Uses:

    For temporary relief of;
    • 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

    and for external itching of;
    •  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 the eyes
    • longer than 1 week unless directed by a physician
    • for diaper rash
    • if you have vaginal discharge
    • more than the recommended daily dosage unless directed by a doctor
    • in the rectum bu using fingers or any other mechanical device or applicator
  • Stop use and ask a physician if:

    • the condition persists or gets worse
    • symptoms clear up and occur again within a few days
    • you are pregnant or breast feeding
  • Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions:

    Adults and children over 2 years of age
    • Apply evenly to affected area no more than 3 or 4 times daily.
    Children under 2 years of age
    • Do not use
    • consult a physician
    Adults
    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
    • Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
    • apply externally to the area up to 6 times daily or after each bowel movement
  • Other information:

    • Store at a controlled room temperature 15 deg - 30 deg C (59 deg - 86 deg F)
    • Avoid excessive heat and humidity
    • tamper evident, do not use if packet is torn, cut or open
  • Inactive ingredients:

    citric acid, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propyl paraben, propylene glycol, purified water, sodium citrate, titanium dioxide,

  • Indications and Usage

    For temporary relief of minor skin irritations and external itching.

  • PRINCIPAL DISPLAY PANEL

    Principal Display

    Hydrocortisone


  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-237
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-237-0112 in 1 CASE
    1144 in 1 BOX
    10.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34802/02/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)