AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]

AVVA (BENZALKONIUM CHLORIDE) GEL [AVVA INTERNATIONAL LLC]
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NDC 42891-4148-0, 42891-4148-1
Set ID 0aadfe31-2d94-4bae-9a6b-081c149c374d
Category HUMAN OTC DRUG LABEL
Packager AVVA International LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Active ingredients
    Benzalkonium Chloride  0.1%    

  • PURPOSE

    Purpose
    Antimicrobial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children if product is swallowed, get medical help or contact a poison control center right away

  • INDICATIONS & USAGE

    Uses:  for vaginal cleansing. Kills germs.

    Directions:
    ·   
    take of any plastic around the tube
    ·    remove the small plastic cap from the top of the applicator
    · gently insert the end with small hole of the applicator deep into the vagina,   while in this position gently push the plunger of the applicator to release the  gel
    ·    remove the applicator and discard it in a waste container
    ·    children under 12 years of age: Ask a doctor

  • GENERAL PRECAUTIONS

    Do not use if the package seal is broken

  • WARNINGS

    Warnings:
    For external use only
    Do not use
    ·    more often than twice weekly unless directed by physician
    ·    to prevent pregnancy
    ·    during pregnancy
    ·    if you have symptoms of pelvic inflammatory disease (PID) or sexually transmitted disease (STD)
    ·    to prevent STD or PID

    When using this product keep out of eyes. Rinse with water to remove

    Stop use and ask doctor if rash, irritation, swelling, pain or redness develops

  • DOSAGE & ADMINISTRATION

    Do not use more often than twice weekly unless directed by physician

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    allantoin, carbomer, glycerin, hydroxyethylcellulose, sodium hydroxide, water

  • PRINCIPAL DISPLAY PANEL

    Carton Image

  • INGREDIENTS AND APPEARANCE
    AVVA 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42891-4148
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE100 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42891-4148-06 in 1 BOX03/28/2012
    1NDC:42891-4148-15.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/28/2012
    Labeler - AVVA International LLC (020023853)

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