GY-NA-TREN (BORIC ACID, LACTOBACILLUS ACIDOPHILUS, VITAMIN C) KIT [NATREN INC.]

GY-NA-TREN (BORIC ACID, LACTOBACILLUS ACIDOPHILUS, VITAMIN C) KIT [NATREN INC.]
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NDC 32267-920-14
Set ID 0ac4b55c-4ad8-4703-aeb2-419d106bf4ea
Category HUMAN OTC DRUG LABEL
Packager Natren Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Boricum Acidum HPUS 3X

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    temporarily relieves symptoms associated with vaginal yeast infections

  • WARNINGS

    For vaginal use only.

  • DO NOT USE

    Do not

    • ingest
    • use if you are pregnant or suspect you are pregnant
    • use while using a tampon
  • ASK DOCTOR

    Ask a doctor before use if you are

    • experiencing vaginal pain
    • having a high fever
    • experiencing vaginal discharge with a foul smell
    • under a doctor's care for any serious condition
    • taking any other drug


  • STOP USE

    Stop use and ask a doctor if you experience

    • vaginal pain
    • high fever
    • severe irritation or burning
    • vaginal discharge with a foul smell
    • symptoms persisting for more than 14 days or if they clear up and occur again within a few days
    • a worsening condition


  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • wash hands before use
    • when vaginal area is clean and dry, using your index finger, gently insert yellow capsule into your vagina as far as comfortable
    • adults and children over 12 years of age:  insert one capsule daily before bedtime.  Repeat for 14 consecutive days.
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING


    • keep dry and refrigerated
    • tamper evident: do not use if seal on bottle is broken
  • INACTIVE INGREDIENT

    Cellulose powder, dehydrated potato powder, gelatin, L-leucine, microcrystalline cellulose

  • QUESTIONS

    Questions or Comments?

    Call 1-800-992-3323 between 7am and 4pm PST

  • PRINCIPAL DISPLAY PANEL


    Gynatren Dietary Supplement Label

    Gynatren Label



  • INGREDIENTS AND APPEARANCE
    GY-NA-TREN 
    boric acid, lactobacillus acidophilus, vitamin c kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:32267-920
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:32267-920-141 in 1 CARTON; Type 0: Not a Combination Product04/30/2012
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 14 
    Part 2 14 
    Part 1 of 2
    GY-NA-TREN  
    lactobacillus acidophilus, vitamin c capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS5000000000 [CFU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID3 mg
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    LEUCINE (UNII: GMW67QNF9C)  
    Product Characteristics
    Coloryellow (none) Scoreno score
    ShapeCAPSULE (none) Size23mm
    FlavorImprint Code none
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/30/2012
    Part 2 of 2
    GY-NA-TREN  
    boric acid suppository
    Product Information
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    GELATIN (UNII: 2G86QN327L)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LEUCINE (UNII: GMW67QNF9C)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2012
    Labeler - Natren Inc. (139705693)
    Registrant - Natren Inc. (139705693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natren Inc.139705693manufacture(32267-920)

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