AVVA VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]

AVVA VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]
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NDC 68915-256-01, 68915-256-02
Set ID 9a46a21f-3e62-4e90-84a2-00e99f3d9e9c
Category HUMAN OTC DRUG LABEL
Packager Eastern Century Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Active ingredients                             Purpose

    Benzalkonium Chloride  0.1%          Antimicrobial


    Uses: for vaginal cleansing. Kills germs.

    Keep out of reach of children

    Stop use and ask doctor if: Rash or irritation and redness develops.

    Discontinue use if any burning, itching, or irritation of the vagina occurs during use. Wash and douche with water. 

    Do not douche to prevent pregnancy

    During pregnancy

    If you have symptoms of pelvic inflammatory disease (PID) or sexually transmitted disease (STD)

    To self treat or prevent a STD or PID

    After exposure to STD stop using this product and consult a doctor if douching results in pain, soreness, swelling, redness, itching excessive dryness or irritation, or symptoms continue after 7 days. These may indicate a serious condition.


    If swallowed, get medical help or contact a poison control center right away.

    External use only

    Do not use in eyes.

    Directions

    Insert the gel into the vagina when cleansing is desired, one unit (5.5 ml) each time.

    Please read the following instructions carefully before use.

    1. Take off any plastic around the tube.

    2. Remove the small plastic tip from the top of the applicator.

    3. Gently insert the small end of the applicator deep into the vagina. While in this position, squeeze the contents of the applicator to release the gel. Remove the applicator and discard it in a waste container.

    Do not use this product if the package seal is broken

    Children under 12 years of age: ask doctor.

    Inactive Ingredients

    Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, sodium hydroxide, water



    image of back of box

  • PRINCIPAL DISPLAY PANEL


    Avva
    Vaginal Douche Gel with Benzalkonium Chloride

    0.18 fl oz  5.5 ml



    Image of front label
  • INGREDIENTS AND APPEARANCE
    AVVA  VAGINAL
    benzalkonium chloride douche
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68915-256
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68915-256-021 in 1 BOX
    1NDC:68915-256-015.5 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2011
    Labeler - Eastern Century Pharmaceuticals (966499373)
    Registrant - GAR Laboratories (074933615)
    Establishment
    NameAddressID/FEIBusiness Operations
    GAR Laboratories074933615manufacture

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