ENVIROTOX- triticum aestivum, berberis vulgaris, lappa major, rhamnus purshiana, senns (cassia angustifolia), phytolacca decandra, glycyrrhiza glabra, stillingia sylvatica, trifolium pratense, xanthoxylum fraxineum, acetonum acetone, sodium tripolyphosphate, propylene glycol, benzinum, ammonium muriaticum, sodium lauryl sulfate, terebinthina, belladonna, lycopodium clavatum, nitricum acidum, nux vomica, phosphoricum acidum, belladonna, lycopodium clavatum, nitricum acidum, nux vomica, phosphoricum acidum. 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:

Triticum Aestivum 1X, Berberis Vulgaris 3X, Lappa Major 3X, Rhamnus Purshiana 3X, Senna (Cassia Angustifolia) 3X, Phytolacca Decandra 4X, Glycyrrhiza Glabra 6X, Stillingia Sylvatica 6X, Trifolium Pratense 6X, Xanthoxylum Fraxineum 6X, Acetonum Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Benzinum 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Belladonna 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X.

INDICATIONS:

For temporary relief of head congestion & general exhaustion as a consequence of exposure to smog, dust, or industrial agents.

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:

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 head congestion & general exhaustion as a consequence of exposure to smog, dust, or industrial agents.

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

ENVIROTOX

HOMEOPATHIC

1 FL OZ (30 ml)

Envirotox

ENVIROTOX
triticum aestivum, berberis vulgaris, lappa major, rhamnus purshiana, senns (cassia angustifolia), phytolacca decandra, glycyrrhiza glabra, stillingia sylvatica, trifolium pratense, xanthoxylum fraxineum, acetonum acetone, sodium tripolyphosphate, propylene glycol, benzinum, ammonium muriaticum, sodium lauryl sulfate, terebinthina, belladonna, lycopodium clavatum, nitricum acidum, nux vomica, phosphoricum acidum, belladonna, lycopodium clavatum, nitricum acidum, nux vomica, phosphoricum acidum. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0625
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU)	TRITICUM AESTIVUM WHOLE	1 [hp_X] in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	3 [hp_X] in 1 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3)	ARCTIUM LAPPA ROOT	3 [hp_X] in 1 mL
FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F)	FRANGULA PURSHIANA BARK	3 [hp_X] in 1 mL
SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX)	SENNA LEAF	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X] in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	6 [hp_X] in 1 mL
STILLINGIA SYLVATICA ROOT (UNII: QBR70R4FBK) (STILLINGIA SYLVATICA ROOT - UNII:QBR70R4FBK)	STILLINGIA SYLVATICA ROOT	6 [hp_X] in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828)	TRIFOLIUM PRATENSE FLOWER	6 [hp_X] in 1 mL
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T)	ZANTHOXYLUM AMERICANUM BARK	6 [hp_X] in 1 mL
ACETONE (UNII: 1364PS73AF) (ACETONE - UNII:1364PS73AF)	ACETONE	9 [hp_X] in 1 mL
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM (UNII: 5HK03SA80J) (TRIPOLYPHOSPHATE ION - UNII:5798IYA5AY)	SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM	9 [hp_X] in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	9 [hp_X] in 1 mL
BENZENE (UNII: J64922108F) (BENZENE - UNII:J64922108F)	BENZENE	9 [hp_X] in 1 mL
AMMONIUM CHLORIDE (UNII: 01Q9PC255D) (AMMONIUM CATION - UNII:54S68520I4)	AMMONIUM CATION	9 [hp_X] in 1 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J) (LAURYL SULFATE - UNII:DIQ16UC154)	SODIUM LAURYL SULFATE	9 [hp_X] in 1 mL
TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F)	TURPENTINE OIL	9 [hp_X] in 1 mL
ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J)	ATROPA BELLADONNA WHOLE	12 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X] in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	12 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	12 [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:43857-0625-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/11/2022

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0625) , api manufacture(43857-0625) , label(43857-0625) , pack(43857-0625)