PRO PH FILLER- hyaluronic acid 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.

----------

crosslinked hyaluronic acid dermal filler

PLLA, Lidocaine

n/a

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

PRO PH FILLER 
hyaluronic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71066-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID1000 g  in 20 mL
Inactive Ingredients
Ingredient NameStrength
LIDOCAINE (UNII: 98PI200987)  
LACTIC ACID (UNII: 33X04XA5AT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71066-0002-110 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(71066-0002)

Revised: 11/2016
Document Id: 4152de40-e1cc-653d-e054-00144ff88e88
Set id: 4152de40-e1cb-653d-e054-00144ff88e88
Version: 1
Effective Time: 20161115
 
PROTOX Inc.