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NDC 32267-0940-14 Gy-Na-Tren Details

Gy-Na-Tren

Gy-Na-Tren is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Natren Inc.. The primary component is .

Product Information

NDC	32267-0940
Product ID	32267-940_d114a69a-cc10-5368-e053-2995a90aa9ac
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Gy-Na-Tren
Proprietary Name Suffix	n/a
Non-Proprietary Name	Boric Acid, Marigold, Coneflower, Arborvitae, Borate of Sodium, Beechwood Kreosote, Wind Flower, Lactobacillus Acidophilus, Vitamin C
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Natren Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 32267-0940-14 (32267094014)

Pricing Information	N/A
NDC Package Code	32267-940-14
Billing NDC	32267094014
Package	1 KIT in 1 CARTON (32267-940-14) * 14 SUPPOSITORY in 1 PACKAGE (32267-941-14)
Marketing Start Date	2016-05-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cee7ff01-dd91-4f9b-86e0-4ac4d7a99c2a Details

SPL UNCLASSIFIED SECTION

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)

SPL UNCLASSIFIED SECTION


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.

SPL UNCLASSIFIED SECTION

Temporarily relieves symptoms associated with vaginal yeast overgrowth.^

SPL UNCLASSIFIED SECTION

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)

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

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

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

(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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Cellulose powder, coconut oil powder, dehydrated potato powder, gelatin, hypromellose, sodium ascorbate, sodium phosphate.

SPL UNCLASSIFIED SECTION

call 1.800.992.3323 between 7am and 4pm Pacific Time

SPL UNCLASSIFIED SECTION

^Indications based on Homeopathic Materia Medica for self limiting conditions.

These statements have not been evaluated by the Food and Drug Administration.

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 kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:32267-940

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:32267-940-14	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	05/02/2016

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1		14
Part 2	1 PACKAGE	14

Part 1 of 2
GY-NA-TREN lactobacillus acidophilus, vitamin c capsule

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	5000000000 [CFU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	2 mg

Ingredient Name	Strength
Inactive Ingredients
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
DIETARY SUPPLEMENT		05/02/2016

Part 2 of 2
GY-NA-TREN boric acid, marigold, coneflower, arborvitae, borate of sodium, beechwood kreosote, wind flower suppository

Product Information
Item Code (Source)	NDC:32267-941
Route of Administration	VAGINAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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]

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:32267-941-14	14 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/02/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/02/2016

Labeler - Natren Inc. (139705693)

Registrant - Natren Inc. (139705693)

Name	Address	ID/FEI	Business Operations
Establishment
Natren Inc.		139705693	manufacture(32267-940, 32267-941)

Revised: 11/2021

Document Id: d114a69a-cc10-5368-e053-2995a90aa9ac

Set id: cee7ff01-dd91-4f9b-86e0-4ac4d7a99c2a

Version: 3

Effective Time: 20211118

Search by Drug Name or NDC

NDC 32267-0940-14 Gy-Na-Tren Details

Gy-Na-Tren

Product Information

Package

Package Images

NDC 32267-0940-14 (32267094014)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL cee7ff01-dd91-4f9b-86e0-4ac4d7a99c2a Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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