Label: RITE AID ORIGINAL STRENGTH VAGICAINE- 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 July 19, 2010

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  • ACTIVE INGREDIENT


    Active ingredient                      Purpose
    Benzocaine 5%............................External analgesic
    Resorcinol 2%...............................External analgesic
  • PURPOSE


    Active ingredient                 Purpose

    Benzocaine 5%.............................External analgesic
    Resorcinol 2%.................................External analgesic

    Use temporarily relieves itching
  • KEEP OUT OF REACH OF CHILDREN


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


    Use     temporarily relieves itching
  • 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

    Keep out of the reach of children.     If swallowed get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION


    Directions

    - adults and children 12 years and older

    apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 or 4 times daily.

    - children under 12 years

    ask a doctor

    Other information

    Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

  • INACTIVE INGREDIENT


    Inactive Ingredients

    aloe barbadebsis 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,
    triethanolamine, trisodium HEDTA, zea mays (corn) oil
  • PRINCIPAL DISPLAY PANEL

    c



  • INGREDIENTS AND APPEARANCE
    RITE AID ORIGINAL STRENGTH VAGICAINE  
    benzocaine and resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2891
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 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)  
    PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    CORN OIL (UNII: 8470G57WFM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-2891-228 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/19/2010
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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