PROTOXIN- clostridium botulinum toxin type a gel 
PROTOX Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Clostridium botulinum Toxin Type A

Normal human serum albumin, Sodium chloride

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.

Confirm the validity of the product label

to make sure the sterilizatios is not damaged before using

N/A

N/A

product label

PROTOXIN 
clostridium botulinum toxin type a gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71066-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOSTRIDIUM BOTULINUM (UNII: 0296055VE0) (CLOSTRIDIUM BOTULINUM - UNII:0296055VE0) CLOSTRIDIUM BOTULINUM10 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALBUMIN HUMAN (UNII: ZIF514RVZR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71066-0001-110 mL in 1 VIAL; Type 0: Not a Combination Product11/10/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/10/2016
Labeler - PROTOX Inc. (689846300)
Registrant - PROTOX Inc. (689846300)
Establishment
NameAddressID/FEIBusiness Operations
PROTOX Inc.689846300manufacture(71066-0001)

Revised: 11/2016
Document Id: 41280d2a-9232-5800-e054-00144ff88e88
Set id: 41280d2a-9231-5800-e054-00144ff88e88
Version: 1
Effective Time: 20161110
 
PROTOX Inc.