Label: GY-NA-TREN- boric acid, lactobacillus acidophilus, vitamin c kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 27, 2020

If you are a consumer or patient please visit this version.

  • 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)