VAX- baptisia tinctoria, echinacea (angustifolia), hydrastis canadensis, tabebuia impetiginosa, trifolium pratense, arnica monta

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y), ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8), GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV), TABEBUIA IMPETIGINOSA BARK (UNII: 6GLA1946WX) (TABEBUIA IMPETIGINOSA BARK - UNII:6GLA1946WX), TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828), ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW), CALENDULA OFFICINALIS FLOWERIN
Available from:
BioActive Nutritional, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of skin irritation, dry cough, eczema, and fever. For temporary relief of skin irritation, dry cough, eczema, and fever.
Authorization status:
unapproved homeopathic
Authorization number:
43857-0297-1

VAX- baptisia tinctoria, echinacea (angustifolia), hydrastis canadensis, tabebuia impetiginosa,

trifolium pratense, arnica montana, calendula officinalis, chelidonium majus, leptandra virginica,

ligusticum porteri, lomatium dissectum, myrrha, nasturtium aquaticum, phytolacca decandra,

taraxacum officinale, trigonella foenum-graecum, urtica dioica, astragalus membranaceus,

propolis, glandula suprarenalis suis, thymus (suis), arsenicum album, belladonna, chamomilla,

lycopodium clavatum, rhus tox, silicea, 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.

----------

DRUG FACTS:

ACTIVE INGREDIENTS:

Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Hydrastis Canadensis 3X, Tabebuia Impetiginosa

3X, Trifolium Pratense 3X, Arnica Montana 4X, Calendula Officinalis 4X, Chelidonium Majus 4X,

Leptandra Virginica 4X, Ligusticum Porteri 4X, Lomatium Dissectum 4X, Myrrha 4X, Nasturtium

Aquaticum 4X, Phytolacca Decandra 4X, Taraxacum Officinale 4X, Trigonella Foenum-Graecum 4X,

Urtica Dioica 4X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Suis 8X, Thymus

(Suis) 8X, Arsenicum Album 12X, Belladonna 12X, Chamomilla 12X, Lycopodium Clavatum 12X, Rhus

Tox 12X, Silicea 30X, Thuja Occidentalis 30X, Antimonium Crudum 30X, 200X, DPT Vaccine 30C,

Thimerosal 30C.

INDICATIONS:

For temporary relief of skin irritation, dry cough, eczema, and fever.

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 skin irritation, dry cough, eczema, and fever.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic

VAX

1 FL OZ (30 ml)

VAX

baptisia tinctoria, echinacea (angustifolia), hydrastis canadensis, tabebuia impetiginosa, trifolium pratense, arnica

montana, calendula officinalis, chelidonium majus, leptandra virginica, ligusticum porteri, lomatium dissectum,

myrrha, nasturtium aquaticum, phytolacca decandra, taraxacum officinale, trigonella foenum-graecum, urtica

dioica, astragalus membranaceus, propolis, glandula suprarenalis suis, thymus (suis), arsenicum album, belladonna,

chamomilla, lycopodium clavatum, rhus tox, silicea, liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:438 57-0 29 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BAPTISIA TINCTO RIA (UNII: 5K1UO28 8 8 Y) (BAPTISIA TINCTORIA -

UNII:5K1UO28 8 8 Y)

BAPTISIA TINCTORIA

3 [hp_X]

in 1 mL

ECHINACEA ANGUSTIFO LIA (UNII: VB0 6 AV5US8 ) (ECHINACEA ANGUSTIFOLIA -

UNII:VB0 6 AV5US8 )

ECHINACEA ANGUSTIFOLIA

3 [hp_X]

in 1 mL

GO LDENSEAL (UNII: ZW3Z11D0 JV) (GOLDENSEAL - UNII:ZW3Z11D0 JV)

GOLDENSEAL

3 [hp_X]

in 1 mL

TABEBUIA IMPETIGINO SA BARK (UNII: 6 GLA19 46 WX) (TABEBUIA

IMPETIGINOSA BARK - UNII:6 GLA19 46 WX)

TABEBUIA IMPETIGINOSA BARK

3 [hp_X]

in 1 mL

TRIFO LIUM PRATENSE FLO WER (UNII: 4JS0 8 38 8 28 ) (TRIFOLIUM PRATENSE

FLOWER - UNII:4JS0 8 38 8 28 )

TRIFOLIUM PRATENSE FLOWER

3 [hp_X]

in 1 mL

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA -

UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

4 [hp_X]

in 1 mL

CALENDULA O FFICINALIS FLO WERING TO P (UNII: 18 E7415PXQ) (CALENDULA

OFFICINALIS FLOWERING TOP - UNII:18 E7415PXQ)

CALENDULA OFFICINALIS

FLOWERING TOP

4 [hp_X]

in 1 mL

CHELIDO NIUM MAJUS (UNII: 7E8 8 9 U5RNN) (CHELIDONIUM MAJUS -

UNII:7E8 8 9 U5RNN)

CHELIDONIUM MAJUS

4 [hp_X]

in 1 mL

VERO NICASTRUM VIRGINICUM RO O T (UNII: M2O6 2YTN42) (CULVER'S ROOT -

UNII:M2O6 2YTN42)

VERONICASTRUM VIRGINICUM

ROOT

4 [hp_X]

in 1 mL

LIGUSTICUM PO RTERI RO O T (UNII: 8 1FGO4H42J) (LIGUSTICUM PORTERI ROOT

- UNII:8 1FGO4H42J)

LIGUSTICUM PORTERI ROOT

4 [hp_X]

in 1 mL

LO MATIUM DISSECTUM RO O T (UNII: 5329 9 28 G5N) (LOMATIUM DISSECTUM

ROOT - UNII:5329 9 28 G5N)

LOMATIUM DISSECTUM ROOT

4 [hp_X]

in 1 mL

MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)

MYRRH

4 [hp_X]

in 1 mL

NASTURTIUM O FFICINALE (UNII: YH8 9 GMV6 76 ) (NASTURTIUM OFFICINALE -

UNII:YH8 9 GMV6 76 )

NASTURTIUM OFFICINALE

4 [hp_X]

in 1 mL

PHYTO LACCA AMERICANA RO O T (UNII: 11E6 VI8 VEG) (PHYTOLACCA

AMERICANA ROOT - UNII:11E6 VI8 VEG)

PHYTOLACCA AMERICANA

ROOT

4 [hp_X]

in 1 mL

TARAXACUM O FFICINALE (UNII: 39 9 8 1FM375) (TARAXACUM OFFICINALE -

UNII:39 9 8 1FM375)

TARAXACUM OFFICINALE

4 [hp_X]

in 1 mL

FENUGREEK SEED (UNII: 6 548 25W0 9 Z) (FENUGREEK SEED - UNII:6 548 25W0 9 Z)

FENUGREEK SEED

4 [hp_X]

in 1 mL

URTICA DIO ICA (UNII: 710 FLW4U46 ) (URTICA DIOICA - UNII:710 FLW4U46 )

URTICA DIOICA

4 [hp_X]

in 1 mL

ASTRAGALUS PRO PINQ UUS RO O T (UNII: 9 22OP8 YUPF) (ASTRAGALUS

PROPINQUUS ROOT - UNII:9 22OP8 YUPF)

ASTRAGALUS PROPINQUUS

ROOT

6 [hp_X]

in 1 mL

PRO PO LIS WAX (UNII: 6 Y8 XYV2NOF) (PROPOLIS WAX - UNII:6 Y8 XYV2NOF)

PROPOLIS WAX

6 [hp_X]

in 1 mL

SUS SCRO FA ADRENAL GLAND (UNII: 39 8 IYQ16 YV) (SUS SCROFA ADRENAL

GLAND - UNII:39 8 IYQ16 YV)

SUS SCROFA ADRENAL GLAND

8 [hp_X]

in 1 mL

SUS SCRO FA THYMUS (UNII: 7B6 9 B0 BD6 2) (SUS SCROFA THYMUS -

UNII:7B6 9 B0 BD6 2)

SUS SCROFA THYMUS

8 [hp_X]

in 1 mL

ARSENIC TRIO XIDE (UNII: S7V9 2P6 7HO) (ARSENIC CATION (3+) -

UNII:C9 6 6 13F5AV)

ARSENIC TRIOXIDE

12 [hp_X]

in 1 mL

ATRO PA BELLADO NNA (UNII: WQZ3G9 PF0 H) (ATROPA BELLADONNA -

UNII:WQZ3G9 PF0 H)

ATROPA BELLADONNA

12 [hp_X]

in 1 mL

CHAMO MILE (UNII: FGL36 8 5T2X) (CHAMOMILE - UNII:FGL36 8 5T2X)

CHAMOMILE

12 [hp_X]

in 1 mL

LYCO PO DIUM CLAVATUM SPO RE (UNII: C8 8 X29 Y479 ) (LYCOPODIUM

CLAVATUM SPORE - UNII:C8 8 X29 Y479 )

LYCOPODIUM CLAVATUM

SPORE

12 [hp_X]

in 1 mL

TO XICO DENDRO N PUBESCENS LEAF (UNII: 6 IO18 2RP7A) (TOXICODENDRON

PUBESCENS LEAF - UNII:6 IO18 2RP7A)

TOXICODENDRON PUBESCENS

LEAF

12 [hp_X]

in 1 mL

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6 XBU4)

SILICON DIOXIDE

30 [hp_X]

in 1 mL

THUJA O CCIDENTALIS LEAFY TWIG (UNII: 1NT28 V9 39 7) (THUJA

THUJA OCCIDENTALIS LEAFY

30 [hp_X]

BioActive Nutritional, Inc.

OCCIDENTALIS LEAFY TWIG - UNII:1NT28 V9 39 7)

TWIG

in 1 mL

ANTIMO NY TRISULFIDE (UNII: F79 0 59 A38 U) (ANTIMONY TRISULFIDE -

UNII:F79 0 59 A38 U)

ANTIMONY TRISULFIDE

30 [hp_X]

in 1 mL

CO RYNEBACTERIUM DIPHTHERIAE TO XO ID ANTIGEN ( FO RMALDEHYDE

INACTIVATED) (UNII: IRH51QN26 H) (CORYNEBACTERIUM DIPHTHERIAE TOXOID

ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26 H)

CORYNEBACTERIUM

DIPHTHERIAE TOXOID ANTIGEN

(FORMALDEHYDE

INACTIVATED)

30 [hp_C]

in 1 mL

CLO STRIDIUM TETANI TO XO ID ANTIGEN ( FO RMALDEHYDE INACTIVATED)

(UNII: K3W1N8 YP13) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE

INACTIVATED) - UNII:K3W1N8 YP13)

CLOSTRIDIUM TETANI TOXOID

ANTIGEN (FORMALDEHYDE

INACTIVATED)

30 [hp_C]

in 1 mL

BO RDETELLA PERTUSSIS (UNII: 2QNL8 20 8 9 R) (BORDETELLA PERTUSSIS -

UNII:2QNL8 20 8 9 R)

BORDETELLA PERTUSSIS

30 [hp_C]

in 1 mL

THIMERO SAL (UNII: 2225PI3MOV) (ETHYLMERCURITHIOSALICYLIC ACID -

UNII:40 71N4J6 4W)

THIMEROSAL

30 [hp_C]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:438 57-

0 29 7-1

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /12/20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 8 /12/20 14

0 5/20 /20 20

Labeler -

BioActive Nutritional, Inc. (624980496)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(438 57-0 29 7) , api manufacture(438 57-0 29 7) , label(438 57-0 29 7) , pack(438 57-

0 29 7)

Revised: 5/2016

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