YEASTAWAY (SODIUM BORATE, CALENDULA OFFICINALIS FLOWERING TOP, CANDIDA ALBICANS, GOLDENSEAL) SUPPOSITORY [LABORATOIRES BOIRON]

YEASTAWAY (SODIUM BORATE, CALENDULA OFFICINALIS FLOWERING TOP, CANDIDA ALBICANS, GOLDENSEAL) SUPPOSITORY [LABORATOIRES BOIRON]
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NDC 0220-9375-62
Set ID c614a4b1-54f4-485c-ac1b-f05b4f94b588
Category HUMAN OTC DRUG LABEL
Packager Laboratoires Boiron
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredients

    Borax 14X, Calendula officinalis 1X, Candida Albicans 30X, Hydrastis canadensis 5X

  • Purpose

    Borax 14X... Reduces thick vaginal discharge
    Calendula officinalis 1X... Healing agent
    Candida Albicans 30X... Relieves symptoms of Candida (yeast) infection
    Hydrastis canadensis 5X...Reduces vaginal discharge

  • Uses*

    See your doctor if this is the first time you have a vaginal itching and discomfort to find out if you have a vaginal yeast infection.
    Temporary relieves symptoms of vaginal yeast infection (candidiasis), such as minor itching, burning, discomfort.

  • Warnings

    For vaginal use only.

    Yeastaway may damage condoms and diaphragms and cause them to fail.

    Ask a doctor before use if you
    have one or more of the following:
    Abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge.
    Get vaginal yeast infections often (such as once a month or three in six months).
    May have been exposed to the human immunodeficiency virus (HIV) that causes AIDS
    Are under 12 years of age.

    When using this product
    Do not use tampons, douche, spermicides
    Do not have vaginal intercourse (sex).

    Stop use and ask doctor if
    symptoms do not improve in 3 days
    symptoms remain after 7 days
    you get abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge or hives.
    These may be signs that this product is not working, or you may have a more serious condition or an allergic reaction.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Before using Yeastaway, read the enclosed educational brochure for complete instructions and information.
    Adults and children 12 years of age and older: Insert one suppository high into the vagina every night for 7 consecutive nights.
    Applicator is included.
    Children under 12 years of age: Ask a doctor

  • Other information

    Do not use if the vaginal suppository seal is broken.

    Do not store above 77 o F (25 o C)

  • SPL UNCLASSIFIED SECTION

    *These "Uses" have not been evaluated by the Food and Drug Administration.

  • Inactive Ingredients

    Gelatin, glycerin, purified water.

  • Questions or comments?

    www.BoironUSA.com
    info@boironusa.com
    1-800-BOIRON-1 (1-800-264-7661)
    Distributed by Boiron Inc.
    6 Campus Boulevard
    Newtown Square, PA
    19073-3267

  • Principle Display Panel - Yeastaway suppository

    Yeastaway image

  • INGREDIENTS AND APPEARANCE
    YEASTAWAY 
    sodium borate, calendula officinalis flowering top, candida albicans, goldenseal suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9375
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE14 [hp_X]
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]
    CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS30 [hp_X]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9375-627 in 1 BOX; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2016
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9375)

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