FDA Label for Gy-na-tren
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Gy-na-tren Product Label
The following document was submitted to the FDA by the labeler of this product Natren Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Boricum acidum 3X 120 mg HPUS (Boric Acid)
Calendula officinalis 1X 120 mg HPUS (Marigold)
Echinacea angustifolia 1X 120 mg HPUS (Coneflower)
Thuja occidentalis 1X 120 mg HPUS (Arborvitae)
Borax veneta 3X 27 mg HPUS (Borate of Sodium)
Kreosotum 12X 27 mg HPUS (Beechwood Kreosote)
Pulsatilla pratensis 30X 27 mg HPUS (Wind Flower)
Otc - Purpose
| Boricum acidum 3X 120 mg HPUS (Boric Acid)
Calendula officinalis 1X 120 mg HPUS (Marigold) Echinacea angustifolia 1X 120 mg HPUS (Coneflower) Thuja occidentalis 1X 120 mg HPUS (Arborvitae) Borax veneta 3X 27 mg HPUS (Borate of Sodium) Kreosotum 12X 27 mg HPUS (Beechwood Kreosote) Pulsatilla pratensis 30X 27 mg HPUS (Wind Flower) | For the relief of external and internal irritation, burning, itching, and discharge associated with vaginal yeast overgrowth.^ |
The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.
Indications & Usage
Temporarily relieves symptoms associated with vaginal yeast overgrowth.^
Warnings
For vaginal use only.
Otc - Do Not Use
Do not
- ingest
- use while using a tampon
- use if you are pregnant or suspect you are pregnant
- use if you have a known hypersensitivity to any ingredient in the product
Otc - Ask Doctor
Ask a doctor before use if you
- experiencing pelvic or vaginal pain
- are having a high fever
- are experiencing vaginal discharge with a foul smell
- are under a doctor's care for any serious condition
- have a sexually tansmitted disease (STD), pelvic inflammatory disease (PID), or urinary tract infection (UTI)
Otc - 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
(for complete directions see insert)
- Wash hands before use
- when vaginal area is clean and dry, using your index finger, gently insert V-capsul into your vagine as far as comfortable
- adults and children over 12 years of age: insert one capsule daily before bedtime
- repeat for 14 consecutive days
- the use of a panty liner is recommended during the application of this product
- 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, coconut oil powder, dehydrated potato powder, gelatin, hypromellose, sodium ascorbate, sodium phosphate.
Otc - Questions
call 1.800.992.3323 between 7am and 4pm Pacific Time
Description
^Indications based on Homeopathic Materia Medica for self limiting conditions.
These statements have not been evaluated by the Food and Drug Administration.
Package Label.Principal Display Panel
* Please review the disclaimer below.