Label: VAGI-CURE (REGULAR STRENGTH)- benzocaine, benzalkonium chloride 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 January 24, 2018

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  • PURPOSE

  • INDICATIONS & USAGE

  • INACTIVE INGREDIENT

  • Directions:

    Apply liberally to affected area. If needed may be repeated three top four times daily. Children under (2) two years of age: Consult a physician.

  • Active ingredients:

    Aloe Vera Gel, Carbomer, Cetyl Alcohol, De-ionized Water, Disodium EDTA, Fragrance, Glycerol Monostearate, Isopropyl Myristate, Isopropyl Palmitate, Lanolin Anhydrous, Methylparaben, Mineral Oil, Peg 100 Stearate, propylene Glycol, Propylparaben, Vitamin E (tocopherol)

  • Warnings:

    FOR EXTERNAL USE ONLY. Avoid contact with eyes.

    Stop use and ask 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 an unusual or abnormal vaginal discharge except under the supervision of a physician. Do not apply over large areas of the body.

    Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STORAGE AND HANDLING

    Store at 15 to 30C (49 to 85F)

    Manufactured for:
    Continental Pharmaceutical Inc.
    5904 Enterprise Court
    Frederick MD 21703
    Web: scimedic.com
    03-0096

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    FAST REFIEF from everyday itch!

    ~Recommended By Women~

    Vagi-cure

    Anti-Itch Cream

    Advanced Sensitive Medicated Cream

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    VAGI-CURE (REGULAR STRENGTH) 
    benzocaine, benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76466-075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76466-075-0721 g in 1 TUBE; Type 0: Not a Combination Product01/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2011
    Labeler - SCI International, Inc. DBA Continental Pharmaceuticals (114220648)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(76466-075)
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