BACTO PLUS HP- apis mellifica, arsenicum album, belladonna, chamomilla, echinacea, lachesis mutus, mercurius solubilis, pulsatilla, pyrogenium liquid
Dr. Elena M. Morreale, Chiropractic Life Center

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:

Apis Mellifica 30X, Arsenicum Album 30X, Belladonna 30X, Chamomilla 30X, Echinacea 30X, Lachesis Mutus 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Pyrogenium 30X, Rhus Toxicodendron 30X, Silicea 30X.

INDICATIONS:

For temporary relief of symptoms of chronic swelling and inflammation of lymph nodes.

WARNINGS:

If pregnant or breast-feeding, ask a health 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:

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

DIRECTIONS:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICIATIONS:

For temporary relief of symptoms of chronic swelling and inflammation of lymph nodes.

INACTIVE INGREDIENTS:

Demineralized Water, 20% Ethanol

QUESTIONS:

Dist. by Dr. Elena M. Morreale

10031 N. Dale Mabry Hwy. Ste. A

Tampa, FL 33618

www.drelenamorreale.com

PACKAGE LABEL DISPLAY:

Dr. Elena M. Morreale
Chiropractic Physician
BACTO PLUS HP
Homeopathic Remedy
1 fl. oz. (30 ml)

Bacto Plus HP

BACTO PLUS HP
apis mellifica, arsenicum album, belladonna, chamomilla, echinacea, lachesis mutus, mercurius solubilis, pulsatilla, pyrogenium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50813-0002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	30 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	30 [hp_X] in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30 [hp_X] in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	30 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	30 [hp_X] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	30 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	30 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_X] in 1 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	30 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	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:50813-0002-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/12/2013	11/17/2019

Labeler - Dr. Elena M. Morreale, Chiropractic Life Center (826038759)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(50813-0002) , api manufacture(50813-0002) , label(50813-0002) , pack(50813-0002)

Revised: 2/2016

Document Id: 00269ef8-664b-47c7-9351-ed553c536595

Set id: 62856a5b-d60e-448b-9dcf-5b167e3ac3a1

Version: 4

Effective Time: 20160218

Dr. Elena M. Morreale, Chiropractic Life Center