MAKESENSE FEMININE ANTI-ITCH (BENZOCAINE BENZALKONIUM CHLORIDE) CREAM [CHERRY HILL SALES CO]

MAKESENSE FEMININE ANTI-ITCH (BENZOCAINE BENZALKONIUM CHLORIDE) CREAM [CHERRY HILL SALES CO]
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NDC 69020-209-21
Set ID 7ab3eaaf-df96-4208-ab73-67d18fad35e6
Category HUMAN OTC DRUG LABEL
Packager Cherry Hill Sales Co
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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