Label: BUDPACK FEMININE ANTI-ITCH- benzocaine benzalkonium chloride 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 May 1, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzocaine 5%

    Benzalkonium Chloride .13%

  • 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 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 of age 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

  • INACTIVE INGREDIENT

    Inactive Ingredients Purified water, Peg-400, Cetearyl Alcohol, Paraffinum Liquidum, Hydroxpropyl Bisstearyldimonium Chloride, Dimethicone, Glyceryl Stearate & Peg-100 Stearate, Diaziolidinyl Urea, Methyparaben, Propylparaben

  • PRINCIPAL DISPLAY PANEL

     Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    BUDPACK  FEMININE ANTI-ITCH
    benzocaine benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE (UNII: OVB1E9X12I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-020-011 in 1 BOX
    1NDC:27293-020-2121 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/21/2012
    Labeler - Budpak Inc. (183224849)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture
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