BACTO PLUS - baptisia tinctoria, echinacea, phytolacca decandra, aconitum napellus, arsenicum album, belladonna, ferrum phosphoricum, lachesis mutus, phosphorus, liquid
Apotheca Company

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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Bacto Plus

ACTIVE INGREDIENTS: Baptisia tinctoria 3X, Echinacea 3X, Phytolacca decandra 3X, Aconitum napellus 12X, Arsenicum album 12X, Belladonna 12X, Ferrum phosphoricum 12X, Lachesis mutus 12X, Phosphorus 12X.

INDICATIONS: For temporary relief of fever, irritated throat and acute irritation of the bladder.

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.

SUGGESTED USE: 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 for use in children under 12 years of age.

INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol.

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 fever, irritated throat, and acute irritation of the bladder.

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
Homeopathic Remedy
1 fl. oz (30 ml)

Bacto Plus

BACTO PLUS
baptisia tinctoria, echinacea, phytolacca decandra, aconitum napellus, arsenicum album, belladonna, ferrum phosphoricum, lachesis mutus, phosphorus, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-1042
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_X] in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	12 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X] in 1 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	12 [hp_X] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	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:57520-1042-1	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		12/30/2011	11/19/2017

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-1042) , api manufacture(57520-1042) , label(57520-1042) , pack(57520-1042)

Revised: 2/2016

Document Id: 2792d03d-1d61-408c-ab9d-025fc374703b

Set id: 2f09c62c-78dc-47a4-8716-384fb02b8f00

Version: 2

Effective Time: 20160217

Apotheca Company