DailyMed - BACTEX (aloe, hydrastis canadensis, allium sativum, anthracinum, bacillus tetani (clostridium tetani), brucella abortus, colibacillinum cum natrum muriaticum, klebsiella pneumoniae, mycoplasma pneumoniae, pneumococcinum, proteus (vulgaris) pseudomonas aeruginosa, staphylococcus aureus, streptococcus viridans, staphysagria, eucalyptol, pyrogenium, lac caninum, lac vaccinum, pertussinum, bacillus cereus, clostridium perfringens, coxiella burnetii- q fever, rickettsia nosode, serratia marcescens spray

NDC Code(s): 83027-0047-1
Packager: Nutritional Specialties, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: unapproved homeopathic

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 Label Information

Updated September 15, 2023

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ACTIVE INGREDIENTS:
Aloe 6X, Hydrastis Canadensis 6X, Allium Sativum 12X, Anthracinum 16X, 30X, Bacillus Tetani 16X, 30X, Brucella Abortus 16X, 30X, Colibacillinum Cum Natrum Muriaticum 16X, 30X, Klebsiella ...

Aloe 6X, Hydrastis Canadensis 6X, Allium Sativum 12X, Anthracinum 16X, 30X, Bacillus Tetani 16X, 30X, Brucella Abortus 16X, 30X, Colibacillinum Cum Natrum Muriaticum 16X, 30X, Klebsiella Pneumoniae 16X, 30X, Mycoplasma Pneumoniae 16X, 30X, Pneumococcinum 16X, 30X, Proteus 16X, 30X, Pseudomonas Aeruginosa 16X, 30X, Staphylococcus Aureus 16X, 30X, Streptococcus Viridans 16X, 30X, Staphysagria 16X, 30X, 100X, Eucalyptol 20X, Pyrogenium 20X, 30X, 100X, Lac Caninum 30X, Lac Vaccinum 30X, Pertussinum 30X, Bacillus Cereus 18C, 30C, Clostridium Perfringens 18C, 30C, Coxiella Burnetii 18C, 30C, Rickettsia Nosode 18C, 30C, Serratia Marcescens 18C, 30C.
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PURPOSE:
Aids in temporary relief of headaches, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.† †Claims based on traditional homeopathic practice, not accepted medical evidence ...

Aids in temporary relief of headaches, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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WARNINGS:
Professional Use Only - If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. If condition ...

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

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

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening
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KEEP OUT OF REACH OF CHILDREN:
In case of overdose, get medical help or contact a Poison Control Center right away.

In case of overdose, get medical help or contact a Poison Control Center right away.
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DIRECTIONS:
Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for ...

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.
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INDICATIONS:
Aids in temporary relief of headaches, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.† †Claims based on traditional homeopathic practice, not accepted medical evidence ...

Aids in temporary relief of headaches, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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INACTIVE INGREDIENTS:
Alcohol USP 20%, Purified Water USP.

Alcohol USP 20%, Purified Water USP.
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QUESTIONS:
MANUFACTURED EXCLUSIVELY FOR - NUTRITIONAL SPECIALTIES, INC. PO BOX 97227 - PITTSBURG, PA 15229 - www.phpltd.com

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com
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PACKAGE LABEL DISPLAY:
Professional - Health Products - HOMEOPATHIC - NDC 83027-0047-1 - BACTEX - 2 FL. OZ (60 ml)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0047-1

BACTEX

2 FL. OZ (60 ml)

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INGREDIENTS AND APPEARANCE

Product Information

BACTEX aloe, hydrastis canadensis, allium sativum, anthracinum, bacillus tetani (clostridium tetani), brucella abortus, colibacillinum cum natrum muriaticum, klebsiella pneumoniae, mycoplasma pneumoniae, pneumococcinum, proteus (vulgaris) pseudomonas aeruginosa, staphylococcus aureus, streptococcus viridans, staphysagria, eucalyptol, pyrogenium, lac caninum, lac vaccinum, pertussinum, bacillus cereus, clostridium perfringens, coxiella burnetii (q fever), rickettsia nosode, serratia marcescens spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83027-0047
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	6 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17)	GARLIC	12 [hp_X] in 1 mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N)	BACILLUS ANTHRACIS IMMUNOSERUM RABBIT	16 [hp_X] in 1 mL
CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (CLOSTRIDIUM TETANI - UNII:751E8J54VM)	CLOSTRIDIUM TETANI	16 [hp_X] in 1 mL
BRUCELLA ABORTUS (UNII: 492LCM0TUL) (BRUCELLA ABORTUS - UNII:492LCM0TUL)	BRUCELLA ABORTUS	16 [hp_X] in 1 mL
ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10)	ESCHERICHIA COLI	16 [hp_X] in 1 mL
KLEBSIELLA PNEUMONIAE (UNII: 09PA36CT5R) (KLEBSIELLA PNEUMONIAE - UNII:09PA36CT5R)	KLEBSIELLA PNEUMONIAE	16 [hp_Q] in 1 mL
MYCOPLASMA PNEUMONIAE (UNII: JQE470FAD0) (MYCOPLASMA PNEUMONIAE - UNII:JQE470FAD0)	MYCOPLASMA PNEUMONIAE	16 [hp_X] in 1 mL
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2)	STREPTOCOCCUS PNEUMONIAE	16 [hp_X] in 1 mL
PROTEUS VULGARIS (UNII: 11T9HCO30O) (PROTEUS VULGARIS - UNII:11T9HCO30O)	PROTEUS VULGARIS	16 [hp_X] in 1 mL
PSEUDOMONAS AERUGINOSA (UNII: Y793W5V55N) (PSEUDOMONAS AERUGINOSA - UNII:Y793W5V55N)	PSEUDOMONAS AERUGINOSA	16 [hp_X] in 1 mL
STAPHYLOCOCCUS AUREUS (UNII: O478WX4004) (STAPHYLOCOCCUS AUREUS - UNII:O478WX4004)	STAPHYLOCOCCUS AUREUS	16 [hp_X] in 1 mL
STREPTOCOCCUS VIRIDANS GROUP (UNII: NNV2379HKR) (STREPTOCOCCUS VIRIDANS GROUP - UNII:NNV2379HKR)	STREPTOCOCCUS VIRIDANS GROUP	16 [hp_X] in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	16 [hp_X] in 1 mL
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	20 [hp_X] in 1 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	20 [hp_X] in 1 mL
CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT)	CANIS LUPUS FAMILIARIS MILK	30 [hp_X] in 1 mL
COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT)	COW MILK	30 [hp_X] in 1 mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED (UNII: U364V64HUN) (HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - UNII:U364V64HUN)	HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED	30 [hp_X] in 1 mL
BACILLUS CEREUS (UNII: 7YC151N82L) (BACILLUS CEREUS - UNII:7YC151N82L)	BACILLUS CEREUS	18 [hp_C] in 1 mL
CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E) (CLOSTRIDIUM PERFRINGENS - UNII:OVP6XX033E)	CLOSTRIDIUM PERFRINGENS	18 [hp_C] in 1 mL
COXIELLA BURNETII (UNII: GRY5SDU86N) (COXIELLA BURNETII - UNII:GRY5SDU86N)	COXIELLA BURNETII	18 [hp_C] in 1 mL
RICKETTSIA PROWAZEKII (UNII: TVS414L9M5) (RICKETTSIA PROWAZEKII - UNII:TVS414L9M5)	RICKETTSIA PROWAZEKII	18 [hp_C] in 1 mL
SERRATIA MARCESCENS (UNII: FB3Y68CF2Y) (SERRATIA MARCESCENS - UNII:FB3Y68CF2Y)	SERRATIA MARCESCENS	18 [hp_C] 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:83027-0047-1	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/15/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/15/2023

Labeler - Nutritional Specialties, Inc. (032744609)

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