PROTOXIN- clostridium botulinum toxin type a gel

PROTOXIN by

Drug Labeling and Warnings

PROTOXIN by is a Otc medication manufactured, distributed, or labeled by PROTOX Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Clostridium botulinum Toxin Type A

INACTIVE INGREDIENT

Normal human serum albumin, Sodium chloride

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS

Confirm the validity of the product label

to make sure the sterilizatios is not damaged before using

DOSAGE & ADMINISTRATION

N/A

INDICATIONS & USAGE

N/A

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTOXIN 
clostridium botulinum toxin type a gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71066-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOSTRIDIUM BOTULINUM (UNII: 0296055VE0) (CLOSTRIDIUM BOTULINUM - UNII:0296055VE0)	CLOSTRIDIUM BOTULINUM	10 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ALBUMIN HUMAN (UNII: ZIF514RVZR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71066-0001-1	10 mL in 1 VIAL; Type 0: Not a Combination Product	11/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/10/2016

Labeler - PROTOX Inc. (689846300)

Registrant - PROTOX Inc. (689846300)

Establishment
Name	Address	ID/FEI	Business Operations
PROTOX Inc.		689846300	manufacture(71066-0001)