Label: ANTI-ITCH FEMININE CARE- hydrocortisone 0.5% cream

  • NDC Code(s): 80489-103-01, 80489-103-02
  • Packager: OL PHARMA TECH, LLC Drs PHARMACY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 8, 2023

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  • ACTIVE INGREDIENT

    Hydrocortisone, USP 0.5%

  • PURPOSE

    Anti-itch

  • USES

    For temporary external feminine itching

  • WARNINGS

    For External Use Only

    Avoid Contact with eyes

  • DIRETIONS

    Adults and children 12 years and older Apply to external vaginal area not more than 3 to 4 times a day
    Children under 12 years Consult a doctor

  • Stop use and ask a doctor if

    • you have a vaginal discharge. Consult a physician.
    • condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again in a few days.
  • KEEP OUT OF REACH OF CHILDREN

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

  • OTHER INFORMATION

    • store at 20°-25°C (68°-77°F)
  • INACTIVE INGREDIENT

    cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

  • QUESTIONS

    www.drspharmacyusa.com

  • PACKAGE LABEL

    feminine care

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH FEMININE CARE 
    hydrocortisone 0.5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80489-103-011 in 1 CARTON02/01/2022
    120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:80489-103-021 in 1 CARTON02/01/2022
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/01/2022
    Labeler - OL PHARMA TECH, LLC Drs PHARMACY (021170377)
    Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHIO LAB PHARMA021170377manufacture(80489-103)
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