VAGI-CURE (MAXIMUM STRENGTH) (BENZOCAINE, RESORCINOL) CREAM [SCI INTERNATIONAL, INC. DBA CONTINENTAL PHARMACEUTICALS]

VAGI-CURE (MAXIMUM STRENGTH) (BENZOCAINE, RESORCINOL) CREAM [SCI INTERNATIONAL, INC. DBA CONTINENTAL PHARMACEUTICALS]
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NDC 76466-010-07
Set ID b4455a7e-e995-482e-b29f-2ec1082dbd91
Category HUMAN OTC DRUG LABEL
Packager SCI International, Inc. DBA Continental Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzocaine 20%

    Resorcinol 3%

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

  • Directions

    apply a fingertip amount adults and children (approximately 1-inch strip) 12 years and older to affected area not more than 3 to 4 times daily children under 12 years consult a doctor

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – TUBE 1 oz (28g) LABEL

    FAST RELIEF from everyday itch!

    ~Recommended By Women~

    Vagi-Cure

    Anti-Itch Cream

    Maximum Strength Medicated Cream

    NET WT 1oz (28g)

    PRINCIPAL DISPLAY PANEL – TUBE 1 oz (28g) LABEL
  • INGREDIENTS AND APPEARANCE
    VAGI-CURE (MAXIMUM STRENGTH) 
    benzocaine, resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76466-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL30 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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76466-010-0728 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(76466-010)

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