TM BIOWATER- bacteriostatic water injection

Drug Labeling and Warnings

Drug Details [pdf]

GENERAL PRECAUTIONS

Sterile Non-Pyrogenic USP <71> Compliant

Do not use if seal is broken or solution is cloudy.

Store at 20 o C-25 o C

(68 o F-77 o F)

Protect from Light.

Refrigerate after opening.

Discard 30 days after first puncture.

For Laboratory and compounding use only.

For sterile prepraration of injectible compounds.

Use only as directed by qualified personnel.

Manufacturer not responsible for improper storage or misuse.

TMBW 30ml

TM BIOWATER

BACTERIOSTATIC WATER (BAC)

Peptide-Grade Sterile Bac Water

0.9% Benzyl Alcohol Added as a Preservative

INGREDIENTS AND APPEARANCE

TM BIOWATER 
bacteriostatic water injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 87597-001
Route of Administration	INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)	BENZYL ALCOHOL	0.9 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87597-001-30	1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product	05/12/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/12/2026

Labeler - TM BIOWATER, INC (142370349)

Registrant - TM BIOWATER, INC (142370349)

Establishment
Name	Address	ID/FEI	Business Operations
TM Biowater, INC		142370349	manufacture(87597-001)