Ovaplex: Homeopathic Product Information

OVAPLEX- angelica archangelica root, caulophyllum thalictroides root, dioscorea villosa tuber, sus scrofa ovary, sus scrofa pituitary gland, sus scrofa thyroid, sus scrofa uterus, zinc gluconate, apis mellifera, atropa belladonna, black cohosh, magnesium phosphate, dibasic trihydrate and sepia officinalis juice 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.

ACTIVE INGREDIENTS:

Angelica Archangelica 3X, Caulophyllum Thalictroides 3X, Dioscorea Villosa 3X, Oophorinum (Suis) 6X, Hypophysis Suis 6X, Thyroidinum (Suis) 6X, Uterus Suis 6X, Zincum Gluconicum 6X, Apis Mellifica 12X, Belladonna 12X, Cimicifuga Racemosa 12X, Magnesia Phosphorica 12X, Sepia 12X.

INDICATIONS:

For temporary relief of painful menses and menstrual cramps.

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 a cool, dry place.

DIRECTIONS:

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

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

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.

INDICATIONS:

For temporary relief of painful menses and menstrual cramps.

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE DISPLAY LABEL:

BIO Active Nutritional
HOMEOPATHIC
OVAPLEX
1 FL OZ (30 mL)

OVAPLEX angelica archangelica, caulophyllum thalictroides, dioscorea villosa, hypophysis suis, oophorinum (suis) thyroidinum (suis), uterus suis, zincum gluconicum, apis mellifica, belladonna, cimicifuga racemosa, magnesia phosphorica, sepia liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0204 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGELICA ARCHANGELICA ROOT (ANGELICA ARCHANGELICA ROOT) ANGELICA ARCHANGELICA ROOT 3 [hp_X] in 1 mL CAULOPHYLLUM THALICTROIDES ROOT (CAULOPHYLLUM THALICTROIDES ROOT) CAULOPHYLLUM THALICTROIDES ROOT 3 [hp_X] in 1 mL DIOSCOREA VILLOSA TUBER (DIOSCOREA VILLOSA TUBER) DIOSCOREA VILLOSA TUBER 3 [hp_X] in 1 mL SUS SCROFA OVARY (SUS SCROFA OVARY) SUS SCROFA OVARY 6 [hp_X] in 1 mL SUS SCROFA PITUITARY GLAND (SUS SCROFA PITUITARY GLAND) SUS SCROFA PITUITARY GLAND 6 [hp_X] in 1 mL SUS SCROFA THYROID (SUS SCROFA THYROID) SUS SCROFA THYROID 6 [hp_X] in 1 mL SUS SCROFA UTERUS (SUS SCROFA UTERUS) SUS SCROFA UTERUS 6 [hp_X] in 1 mL ZINC GLUCONATE (ZINC CATION) ZINC GLUCONATE 6 [hp_X] in 1 mL APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 12 [hp_X] in 1 mL ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 12 [hp_X] in 1 mL BLACK COHOSH (BLACK COHOSH) BLACK COHOSH 12 [hp_X] in 1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 12 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43857-0204-1 30 mL in 1 BOTTLE, DROPPER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/21/2013

Labeler — BioActive Nutritional, Inc. (624980496)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (43857-0204), api manufacture (43857-0204), label (43857-0204), pack (43857-0204)

Revised: 03/2018 BioActive Nutritional, Inc.