Label: MAKESENSE 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 August 11, 2014

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  • Active Ingredients

    Benzocaine 5%

    Benzalkonium Chloride .13%

  • Purpose

    External Analgesic

    External Antiseptic

  • Uses

    ■ temporarily relieves itching

  • Warnings

    For external use only

    Avoid contact with eyes

  • Stop use and ask a doctor

    ■ condition or symptoms worsens ■ symptoms do not improve in 7 days ■ if symptoms clear up and occur again within a few days

    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

  • 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 ingredients

    Cetearyl Alcohol, Diaziolidinyl Urea, Dimethicone, Glyceryl Stearate, Hydroxpropyl Bisstearyldimonium Chloride, Methyparaben, Peg-100 Stearate, Peg-400, Propylparaben, Purified water

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MAKESENSE  FEMININE ANTI-ITCH
    benzocaine benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-209
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE (UNII: OVB1E9X12I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-209-2121 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/31/2014
    Labeler - Cherry Hill Sales Co (145959768)
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