PRO PH FILLER- hyaluronic acid gel

PRO PH Filler by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

crosslinked hyaluronic acid dermal filler

INACTIVE INGREDIENT

PLLA, Lidocaine

PURPOSE

n/a

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

PRO PH FILLER 
hyaluronic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71066-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONIC ACID	1000 g  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
LIDOCAINE (UNII: 98PI200987)
LACTIC ACID (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71066-0002-1	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(71066-0002)