NDC | 32267-940-14, 32267-941-14 |
Set ID | cee7ff01-dd91-4f9b-86e0-4ac4d7a99c2a |
Category | HUMAN OTC DRUG LABEL |
Packager | Natren Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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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)
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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
-
WARNINGS
For vaginal use only.
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
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)
-
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
- INACTIVE INGREDIENT
- QUESTIONS
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GY-NA-TREN
boric acid, marigold, coneflower, arborvitae, borate of sodium, beechwood kreosote, wind flower, lactobacillus acidophilus, vitamin c kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:32267-940 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:32267-940-14 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 05/02/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 14 Part 2 1 PACKAGE 14 Part 1 of 2 GY-NA-TREN
lactobacillus acidophilus, vitamin c capsuleProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS 5000000000 [CFU] ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 2 mg Inactive Ingredients Ingredient Name Strength POWDERED CELLULOSE (UNII: SMD1X3XO9M) LEUCINE (UNII: GMW67QNF9C) POTATO (UNII: CFE1S8DYWD) CHICKPEA (UNII: N91637DNW9) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Product Characteristics Color yellow (none) Score no score Shape CAPSULE (none) Size 23mm Flavor Imprint Code none Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 05/02/2016 Part 2 of 2 GY-NA-TREN
boric acid, marigold, coneflower, arborvitae, borate of sodium, beechwood kreosote, wind flower suppositoryProduct Information Item Code (Source) NDC:32267-941 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID 3 [hp_X] WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE 12 [hp_X] SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 3 [hp_X] PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS 30 [hp_X] CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 1 [hp_X] THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X] Inactive Ingredients Ingredient Name Strength POWDERED CELLULOSE (UNII: SMD1X3XO9M) GELATIN (UNII: 2G86QN327L) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) COCONUT OIL (UNII: Q9L0O73W7L) POTATO (UNII: CFE1S8DYWD) SODIUM ASCORBATE (UNII: S033EH8359) SODIUM PHOSPHATE (UNII: SE337SVY37) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:32267-941-14 14 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/02/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/02/2016 Labeler - Natren Inc. (139705693) Registrant - Natren Inc. (139705693) Establishment Name Address ID/FEI Business Operations Natren Inc. 139705693 manufacture(32267-940, 32267-941)