PROTOXIN

Manufacturer: PROTOX Inc.
Effective date: 2016-11-10
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:47:59

Label at a glance#

ProductPROTOXIN

Active ingredientCLOSTRIDIUM BOTULINUM

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Clostridium botulinum Toxin Type A

INACTIVE INGREDIENT SECTION

Normal human serum albumin, Sodium chloride

OTC - PURPOSE SECTION

Stop a secretion of the neurotransmitter acetylcholine in a place to see nerves and muscles.
Lessening the rigidity of the child with cerebral palsy using the qualities that lead to muscle paralysis.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

Confirm the validity of the product label

to make sure the sterilizatios is not damaged before using

DOSAGE & ADMINISTRATION SECTION

N/A

INDICATIONS & USAGE SECTION

N/A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71066-0001-1	2020-01-31	C162847	48780-1	9d75b9d1-11cd-f424-e053-dadaa90a57ce	41280d2a-9231-5800-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71066-0001-1	PROTOXIN	10 mL in 1 VIAL	GEL	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71066-0001	PROTOXIN (CLOSTRIDIUM BOTULINUM TOXIN TYPE A) GEL [PROTOX INC.]	1	Legacy NDC, 1 package rows	20161114_41280d2a-9231-5800-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

PROTOXIN
Clostridium botulinum Toxin Type A
ALBUMIN HUMAN
SODIUM CHLORIDE
CLOSTRIDIUM BOTULINUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71066-0001	71066-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALBUMIN HUMAN	ZIF514RVZR	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
CLOSTRIDIUM BOTULINUM	0296055VE0	ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
41280d2a-9232-5800-e054-00144ff88e88			41280d2a-9231-5800-e054-00144ff88e88	2016-11-10	Warnings	Exact identifier spl id: 41280d2a-9232-5800-e054-00144ff88e88 spl set id: 41280d2a-9231-5800-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.