Label: 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 September 25, 2017

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  • Active ingredient

    Hydrocortisone 1.0%

  • Purpose

    Anti-itch

  • Uses

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

    • cosmetics
    • soaps
    • jewelry
    • insect bites
    • psoriasis
    • eczema
    • detergents
    • seborrheic dermatitis
    • external genital and anal itching
    • poison ivy, poison oak, or poison sumac

    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 the treatment of diaper rash. Consult a doctor.
    • for external genital itching if you have vaginal discharge. Consult a doctor.
  • When using this product

    • avoid contact with eyes   
    • do not use more than directed unless told to do so 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor  
    • rectal bleeding occurs
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • 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, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product
    • children under 12 years of age with external anal itching: consult a doctor
  • Other information

    • store at 15° to 30°C (59° to 86°F)
    • lot number and expiration date: See crimp of tube or box

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

  • Inactive ingredients

    cetyl alcohol, diazolidinyl urea, isopropyl palmitate, mineral oil/lanolin alcohol, polysorbate 40, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol, xanthan gum

  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 5/15 R6
    8265556  0534

  • HOW SUPPLIED

    Product: 50090-0232

    NDC: 50090-0232-0 28.4 g in a TUBE

  • hydrocortisone

    Label Image
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0232(NDC:0603-0535)
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    POLYSORBATE 40 (UNII: STI11B5A2X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
    WATER (UNII: 059QF0KO0R)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0232-01 in 1 CARTON11/28/2014
    1 28.4 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 FINALpart34810/01/2001
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0232)
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