VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA (HYDROCORTISONE ACETATE) CREAM [COMBE INCORPORATED]

  • Home
  • VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA (HYDROCORTISONE ACETATE) CREAM [COMBE INCORPORATED]

VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA (HYDROCORTISONE ACETATE) CREAM [COMBE INCORPORATED]
PDF | XML
NDC 11509-5101-1
Set ID 9b69fa24-02dd-43e4-a81f-9a37968d7099
Category HUMAN OTC DRUG LABEL
Packager Combe Incorporated
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • SPL UNCLASSIFIED SECTION

    Vagisil Anti-Itch Crème Maximum Strength, Sensitive Skin Formula

    Drug Facts

  • Active Ingredient

    Hydrocortisone Acetate, 1%

  • Purpose

    Anti-itch

  • Use

    For temporary external feminine itching

  • Warnings

    For External Use Only

    Avoid Contact with eyes

    Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again in a few days.

    Do not use if

    you have a vaginal discharge. Consult a physician.

    Keep out of reach of children.

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

  • Directions

    Adults and children 12 years and olderApply to external vaginal area not more than 3 to 4 times a day
    Children under 12 yearsConsult a doctor
  • Inactive Ingredients:

    water, cetyl ethylhexanoate, glycerin , PEG-40 hydrogenated castor oil , glyceryl dilaurate, dimethicone, colloidal oatmeal, aloe barbadensis leaf extract, sodium polyacrylate, caprylyl glycol ,ceteareth-20, glyceryl oleate , acrylates/C10-30 alkyl acrylate crosspolymer, cyclopentasiloxane, trideceth-6, sodium hydroxide, disodium EDTA, sorbic acid, PEG/PPG-18/18 dimethicone, tocopheryl acetate, maltodextrin, phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    Vagisil Anti-Itch Crème Maximum Strength, Sensitive Skin Formula, 1% Hydrocortisone
    1 oz (28 g)

    Vagisil Anti-Itch Crème Maximum Strength, Sensitive Skin Formula, 1% Hydrocortisone 1 oz (28 g)

  • INGREDIENTS AND APPEARANCE
    VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE280 mg  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OATMEAL (UNII: 8PI54V663Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBIC ACID (UNII: X045WJ989B)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11509-5101-128 g in 1 CARTON; Type 0: Not a Combination Product01/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/30/2016
    Labeler - Combe Incorporated (002406502)
View All Sections

Related Drugs

Search DailyMed Drugs