GYNETOX- angelica archangelica, cimicifuga racemosa, zincum gluconicum, funiculus umbilicalis suis, lymph node (suis), oophorinum (suis), uterus (suis), glandula suprarenalis suis, thyroidinum suis, boricum acidum, kreosotum, mercurius solubilis, pulsatilla (pratensis), sepia, calcarea carbonica, phosphorus, sabina, candida albicans, herpes simplex 1 and 2 nosode, human papilloma nosode liquid
BioActive Nutritional, Inc.

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.

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Drug Facts:

ACTIVE INGREDIENTS:

Angelica Archangelica, Cimicifuga Racemosa, Zincum Gluconicum, Funiculus Umbilicalis Suis, Lymph Node (Suis), Oophorinum (Suis), Uterus (Suis), Glandula Suprarenalis Suis, Thyroidinum Suis, Boricum Acidum, Kreosotum, Mercurius Solubilis, Pulsatilla (Pratensis), Sepia, Calcarea Carbonica, Phosphorus, Sabina, Candida Albicans, Herpes Simplex 1 And 2 Nosode, Human Papilloma Nosode

INDICATIONS:

For temporary relief of menstrual pain and vaginal irritation.

WARNINGS:

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of menstrual pain and vaginal irritation.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional
GYNETOX
HOMEOPATHIC
1 FL OZ (30 ml)

Gynetox

GYNETOX
angelica archangelica, cimicifuga racemosa, zincum gluconicum, funiculus umbilicalis suis, lymph node (suis), oophorinum (suis), uterus (suis), glandula suprarenalis suis, thyroidinum suis, boricum acidum, kreosotum, mercurius solubilis, pulsatilla (pratensis), sepia, calcarea carbonica, phosphorus, sabina, candida albicans, herpes simplex 1 and 2 nosode, human papilloma nosode liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0565
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN) (ANGELICA ARCHANGELICA ROOT - UNII:DTN01M69SN)	ANGELICA ARCHANGELICA ROOT	3 [hp_X] in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	3 [hp_X] in 1 mL
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	6 [hp_X] in 1 mL
SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H)	SUS SCROFA UMBILICAL CORD	8 [hp_X] in 1 mL
SUS SCROFA LYMPH (UNII: 33A7VYU29L) (SUS SCROFA LYMPH - UNII:33A7VYU29L)	SUS SCROFA LYMPH	8 [hp_X] in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	8 [hp_X] in 1 mL
SUS SCROFA UTERUS (UNII: 2595C75F1P) (SUS SCROFA UTERUS - UNII:2595C75F1P)	SUS SCROFA UTERUS	8 [hp_X] in 1 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	9 [hp_X] in 1 mL
SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ)	SUS SCROFA THYROID	9 [hp_X] in 1 mL
BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4)	BORIC ACID	12 [hp_X] in 1 mL
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	12 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	12 [hp_X] in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_X] in 1 mL
JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1)	JUNIPERUS SABINA LEAFY TWIG	30 [hp_X] in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	30 [hp_X] in 1 mL
HUMAN HERPESVIRUS 1 (UNII: 22G38P19RL) (HUMAN HERPESVIRUS 1 - UNII:22G38P19RL)	HUMAN HERPESVIRUS 1	30 [hp_X] in 1 mL
HUMAN HERPESVIRUS 2 (UNII: 74J6DNH49U) (HUMAN HERPESVIRUS 2 - UNII:74J6DNH49U)	HUMAN HERPESVIRUS 2	30 [hp_X] in 1 mL
HUMAN PAPILLOMAVIRUS (UNII: 23CVL7WF4J) (HUMAN PAPILLOMAVIRUS - UNII:23CVL7WF4J)	HUMAN PAPILLOMAVIRUS	30 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0565-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/18/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/18/2021

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0565) , api manufacture(43857-0565) , label(43857-0565) , pack(43857-0565)