VAGI-CURE ADVANCED SENSITIVE MEDICATED (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [SCI INTERNATIONAL, INC. DBA CONTINENTAL PHARMACEUTICALS]

VAGI-CURE ADVANCED SENSITIVE MEDICATED (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [SCI INTERNATIONAL, INC. DBA CONTINENTAL PHARMACEUTICALS]
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NDC 76466-011-07
Set ID 624a948a-8db6-4834-aead-ed8dfbe97e03
Category HUMAN OTC DRUG LABEL
Packager SCI International, Inc. DBA Continental Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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