Label: BENZOCAINE AND 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 February 16, 2011

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  • ACTIVE INGREDIENT

    Active ingredients                      Purpose
    Benzocaine 20%....................External Analgesic
    Resorcinol 3%........................External Analgesic
  • PURPOSE

    Usetemporarily relieves itching
  • KEEP OUT OF REACH OF CHILDREN


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

    Use temporarily relieves itching

    Other information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)

  • WARNINGS

    Warnings
    For external use only.
    _______________________________________________________________

    When using this product avoid contact with the 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 over large areas of the body
    _______________________________________________________________

  • DOSAGE & ADMINISTRATION


    Directions  adults and                       apply a fingertip amount (approximately
                       children 12 years             1 inch strip) to the affected area not
                       and older                         more than 3 to 4 times daily
                       _______________________________________________________
                      
                       children under 12 years    ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients aloe barbadensis leaf extract, carbomer, cetyl
    alcohol, cholecalciferol, fragrance, glyceryl stearate, isopropyl myristate, isopropyl
    palmitate, isopropyl stearate, lanolin alcohol, methylparaben, mineral oil, PEG-100
    stearate, propylene glycol, purified water, retinyl palmitate, sodium sulfite, tocopheryl
    acetate, trisodium HEDTA, triethanolamine, zea mays (corn) oil
  • PRINCIPAL DISPLAY PANEL

    label


  • INGREDIENTS AND APPEARANCE
    BENZOCAINE AND RESORCINOL 
    benzocaine and resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-810
    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) RESORCINOL20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-810-241 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/19/2009
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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