Label: VAGI-CURE ADVANCED SENSITIVE MEDICATED- 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 February 24, 2022

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  • Active ingredients

    Benzocaine                     5%

    Benzalkonium Chloride  .13%

  • Purpose

    External Analgesic

    External Antiseptic

  • Uses

    • Temporarily relieves itching
  • 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 apply over large areas of the body

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

  • Directions

    adult and children 2 years and older

    apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.

    children under 2 years

    consult a doctor

  • Inactive 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 (Tocopheryl Acetate). 

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL 

    Vagi-Cure

    Anti-Itch Cream

    Advance Sensitive Medicated Cream

    NET WT 0.75oz (21g)

    label of vagi-cure advance

  • INGREDIENTS AND APPEARANCE
    VAGI-CURE ADVANCED SENSITIVE MEDICATED 
    benzocaine, benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76466-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    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:76466-011-0721 g in 1 TUBE; Type 0: Not a Combination Product06/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2016
    Labeler - SCI International, Inc. DBA Continental Pharmaceuticals (114220648)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(76466-011)
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