Label: VAGICAINE MAXIMUM STRENGTH ANTI-ITCH CREAM- 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 April 18, 2016

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  • Active Ingredients

    Benzocaine 20%

    Resorcinol 3%

  • Purpose

    External Analgesic

    External Analgesic

  • INDICATIONS & USAGE

    Temporarily relieves itching

  • Warnings

    For external use only

    When using this product avoid contact with the 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

    adults and children 12 years and olderapply a fingertip amount (appriximately 1-inch strip) to the affected area not more than 3 to 4 times daily
    children under 12 yearsask a doctor

  • Other Information

    • store at 20º-25ºC (68º - 77ºF)
  • Inactive Ingredients

    Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, PEG-100 Stearate and Glyceryl Monostearate, PEG-40 Hydrogenated Castor Oil, Isopropyl Palmitate, Carbomer, Triethanolamine, Methylparaben, Tocopheryl Acetate, Hydroxyethylcelluse, Xanthan Gum, Maltodextrin, Propylparaben, Disodium EDTA, Aloe Barbadensis (Alow Vera) Leaf Extract, Fragrance

  • PRINCIPAL DISPLAY PANEL

    Maximum Strength

    Vagicaine

    Medicated anti-itch cream

    Net Wt 1 oz (28g)

    CVS Health TM Maximum Strength Vagicaine Medicaided Anti-Itch Cream provides instant relief from painful, burning itch using the power of benzocaine and resorcinol combined with the soothing vitamin E plus aloe.

    *This product is not manufactured or distributed by Combe Inc., owner of the registered trademark Vagisil TM maximum Strength Anti-Itch Cream

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02995

    (c) 2016 CVS/pharmacy

    CVS.com (R) 1-800-SHOP CVS V-31535

    CVS (R) Quality

    Money Back Guarantee

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    VAGICAINE MAXIMUM STRENGTH ANTI-ITCH CREAM 
    benzocaine, resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-588
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5.6 g  in 28 g
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL0.84 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-588-011 in 1 CARTON05/01/2016
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2016
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioZone Laboratories, Inc.555564293manufacture(59779-588)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioZone Laboratories, Inc962455320manufacture(59779-588)
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