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 
Nutritional Specialties, 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:

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.

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. Not FDA evaluated.

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 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

KEEP OUT OF REACH OF CHILDREN:

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

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 use in children under 12 years of age.

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. Not FDA evaluated.

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0047-1

BACTEX

2 FL. OZ (60 ml)

BACTEX

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0047
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC12 [hp_X]  in 1 mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N) BACILLUS ANTHRACIS IMMUNOSERUM RABBIT16 [hp_X]  in 1 mL
CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (CLOSTRIDIUM TETANI - UNII:751E8J54VM) CLOSTRIDIUM TETANI16 [hp_X]  in 1 mL
BRUCELLA ABORTUS (UNII: 492LCM0TUL) (BRUCELLA ABORTUS - UNII:492LCM0TUL) BRUCELLA ABORTUS16 [hp_X]  in 1 mL
ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI16 [hp_X]  in 1 mL
KLEBSIELLA PNEUMONIAE (UNII: 09PA36CT5R) (KLEBSIELLA PNEUMONIAE - UNII:09PA36CT5R) KLEBSIELLA PNEUMONIAE16 [hp_Q]  in 1 mL
MYCOPLASMA PNEUMONIAE (UNII: JQE470FAD0) (MYCOPLASMA PNEUMONIAE - UNII:JQE470FAD0) MYCOPLASMA PNEUMONIAE16 [hp_X]  in 1 mL
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2) STREPTOCOCCUS PNEUMONIAE16 [hp_X]  in 1 mL
PROTEUS VULGARIS (UNII: 11T9HCO30O) (PROTEUS VULGARIS - UNII:11T9HCO30O) PROTEUS VULGARIS16 [hp_X]  in 1 mL
PSEUDOMONAS AERUGINOSA (UNII: Y793W5V55N) (PSEUDOMONAS AERUGINOSA - UNII:Y793W5V55N) PSEUDOMONAS AERUGINOSA16 [hp_X]  in 1 mL
STAPHYLOCOCCUS AUREUS (UNII: O478WX4004) (STAPHYLOCOCCUS AUREUS - UNII:O478WX4004) STAPHYLOCOCCUS AUREUS16 [hp_X]  in 1 mL
STREPTOCOCCUS VIRIDANS GROUP (UNII: NNV2379HKR) (STREPTOCOCCUS VIRIDANS GROUP - UNII:NNV2379HKR) STREPTOCOCCUS VIRIDANS GROUP16 [hp_X]  in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED16 [hp_X]  in 1 mL
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL20 [hp_X]  in 1 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF20 [hp_X]  in 1 mL
CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT) CANIS LUPUS FAMILIARIS MILK30 [hp_X]  in 1 mL
COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK30 [hp_X]  in 1 mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED (UNII: U364V64HUN) (HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - UNII:U364V64HUN) HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED30 [hp_X]  in 1 mL
BACILLUS CEREUS (UNII: 7YC151N82L) (BACILLUS CEREUS - UNII:7YC151N82L) BACILLUS CEREUS18 [hp_C]  in 1 mL
CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E) (CLOSTRIDIUM PERFRINGENS - UNII:OVP6XX033E) CLOSTRIDIUM PERFRINGENS18 [hp_C]  in 1 mL
COXIELLA BURNETII (UNII: GRY5SDU86N) (COXIELLA BURNETII - UNII:GRY5SDU86N) COXIELLA BURNETII18 [hp_C]  in 1 mL
RICKETTSIA PROWAZEKII (UNII: TVS414L9M5) (RICKETTSIA PROWAZEKII - UNII:TVS414L9M5) RICKETTSIA PROWAZEKII18 [hp_C]  in 1 mL
SERRATIA MARCESCENS (UNII: FB3Y68CF2Y) (SERRATIA MARCESCENS - UNII:FB3Y68CF2Y) SERRATIA MARCESCENS18 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83027-0047-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/15/2023
Labeler - Nutritional Specialties, Inc. (032744609)

Revised: 9/2023
Document Id: f5307c70-b68b-4d37-aabe-0139c0b587df
Set id: c6055c02-a365-4adf-9d3a-47d717c4c93d
Version: 1
Effective Time: 20230915
 
Nutritional Specialties, Inc.