Label: VAGI-CURE (MAXIMUM STRENGTH)- benzocaine, resorcinol 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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  • 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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