VAGI CARE (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [PERSONAL CARE PRODUCTS]

VAGI CARE (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [PERSONAL CARE PRODUCTS]
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NDC 29500-2264-1
Set ID 4ff50f17-7679-4a7a-994a-bda6cd23cb90
Category HUMAN OTC DRUG LABEL
Packager Personal Care Products
Generic Name
Product Class
Product Number
Application Number PART348
  • Vagi Care

    For external use only.

    Avoid contact with eyes. In case of eye contact, flush with plenty of water. If irritation persist, seek medical advice.

    Stop use and ask a doctor if conditin worsens, or if symptoms persist for more than 7 days or clear up and reoccur within a few days.

    Do not apply over large areas of skin.

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzocaine 5.0%

    Benzalkonium Chloride 0.13%

  • WARNINGS

    warnings

    For external use only.

    Avoid contact with eyes. In case of eye contact flush with plenty of water. If irritation persist, seek medical advice.

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur within a few days.

    Do not apply over large areas of skin.

  • DOSAGE & ADMINISTRATION

    Directions adults and children 2 years and older-Apply fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily

    children under 2 years-consult a doctor

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Uses temporarily relieves itching

  • PURPOSE

    Purpose External Analgesic

  • INACTIVE INGREDIENT

    Aloe Barbadensis (aloe vera) gel, cetryl alcohol, diazolidinyl urea, dimethicone, glycol stearate, hydroxypropyl bisstearyldimonium chloride, methyl paraben, mineral oil, PEG 100 stearate, PEG 400, propyl paraben, prified water, tocopheryl acetate (vitamin e)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    VAGI CARE 
    benzocaine, benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2264
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) benzocaine1.050 g  in 21.000 g
    benzalkonium chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) benzalkonium chloride.003 g  in 21.000 g
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    cetyl alcohol (UNII: 936JST6JCN)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    dimethicone (UNII: 92RU3N3Y1O)  
    glycol stearate (UNII: 0324G66D0E)  
    hydroxypropyl bisstearyldimonium chloride (UNII: OVB1E9X12I)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    .alpha.-tocopherol (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-2264-121 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2013
    Labeler - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals916837425manufacture(29500-2264)

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