Label: BUDPAK FEMININE ANTI-ITCH- 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 June 8, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients

    Benzocaine 5%

    Resorcinol 2%

  • PURPOSE

    Purpose

    External analgesic

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves itching
  • WARNINGS

    Warnings

    For external use only

    Avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if condition worsens or if symptoms 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

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

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children, 2 years and older:

    • Apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.

    Children under 2 years of age: Consult a doctor

  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at room temperature 15°C to 30°C (59°F to 86°F).
    • Lot No. Exp. Date: see crimp of the tube.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified water, cetyl alcohol, glyceryl stearate, PEG-100 stearate, mineral oil, isopropyl palmitate, aloe barbadensis leaf juice, alpha tocopherol acetate, corn oil, cholecalciferol, methyl paraben, isopropyl myristate, sodium sulfite, trolamine, trisodium HEDTA, vitamin A palmitate, carbomer homopolymer type c.

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Budpak Feminine Anti-Itch Cream

    Benzocaine 5%

    Resorcinol 2%

    External analgesic

    NET WT 0.75 OZ (21.2 g)

  • PRINCIPAL DISPLAY PANEL

    image of package label

  • INGREDIENTS AND APPEARANCE
    BUDPAK FEMININE ANTI-ITCH 
    benzocaine and resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.05 g  in 1 g
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN OIL (UNII: 8470G57WFM)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-022-011 in 1 BOX
    1NDC:27293-022-2121.2 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/10/2013
    Labeler - Budpak Inc. (183224849)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-022)
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