Label: MEIJER MAXIMUM STRENGTH VAGICAINE- benzocaine, resorcinol cream

  • NDC Code(s): 79481-0006-1
  • Packager: Meijer Distribution Inc
  • 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 July 28, 2023

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  • Active ingredients

    Benzocaine 20%

    Resorcinol 3%

  • Purpose

    External analgesic

  • Use

    temporarily relieves itching

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes

    Stop use and ask a 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

    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. (1-800-222-1222)

    Directions


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

  • Other information

    ■ store at 20º-25ºC (68º-77ºF)

  • Inactive Ingredients


    aloe barbadensis leaf extract, carbomer, cetyl alcohol, cholecalciferol, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, purified water, retinyl palmitate, sodium hydroxide, sodium sulfate, tocopheryl acetate, trisodium HEDTA

  • Questions or comments

    Call toll-free 1-866-326-1313

  • Meijer Maximum Strength Vagicaine Cream

    labelpackage

  • INGREDIENTS AND APPEARANCE
    MEIJER MAXIMUM STRENGTH VAGICAINE 
    benzocaine, resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL0.84 g  in 28 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5.6 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0006-128.3 g in 1 TUBE; Type 0: Not a Combination Product07/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2023
    Labeler - Meijer Distribution Inc (006959555)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(79481-0006)
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