HOUSEHOLD ANTIGENS- acetone, sodium tripolyphosphate, propylene glycol, benzinum, ammonium muriaticum, sodium lauryl sulfate, terebinthina, anacardium orientale, graphites, nitricum acidum, pulsatilla (pratensis), sulphur liquid
BioActive Nutritional

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:

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, Anacardium Orientale 12X, Graphites 12X, Nitricum Acidum 12X, Pulsatilla (Pratensis) 12X, Sulphur 12X.

PURPOSE:

For the temporary relief of allergies due to household products.

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.

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 the temporary relief of allergies due to household products.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

*For a complete list of Environmental Isode Contact BioActive Nutritional, Inc.

PACKAGE DISPLAY LABEL:

BIOActive Nutritional

HOUSEHOLD ANTIGENS

HOMEOPATHIC

1 FL OZ (30 ml)

Household Antigens

HOUSEHOLD ANTIGENS
acetone, sodium tripolyphosphate, propylene glycol, benzinum, ammonium muriaticum, sodium lauryl sulfate, terebinthina, anacardium orientale, graphites, nitricum acidum, pulsatilla (pratensis), sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0537
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETONE (UNII: 1364PS73AF) (ACETONE - UNII:1364PS73AF)	ACETONE	9 [hp_X] in 1 mL
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J) (TRIPOLYPHOSPHATE ION - UNII:5798IYA5AY)	SODIUM TRIPOLYPHOSPHATE	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
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU)	SEMECARPUS ANACARDIUM JUICE	12 [hp_X] in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	12 [hp_X] in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	12 [hp_X] in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI)	PULSATILLA PRATENSIS WHOLE	12 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	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:43857-0537-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/08/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/08/2019

Labeler - BioActive Nutritional (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0537) , api manufacture(43857-0537) , label(43857-0537) , pack(43857-0537)