Label: VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA- hydrocortisone acetate 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 April 20, 2020

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  • SPL UNCLASSIFIED SECTION

    Vagisil Sensitive Skin Anti-Itch Creme 

    Drug Facts

  • Active ingredients

    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 within 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 Sensitive Skin Anti-Itch Creme, 1% Hydrocortisone
    Net. Wt. 1 oz. (28 g)

    Vagisil Sensitive Skin Anti-Itch Creme, 1% Hydrocortisone Net. Wt. 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)
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