Label: PRO PH FILLER- hyaluronic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated November 15, 2016

If you are a consumer or patient please visit this version.

  • 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

    product label

  • INGREDIENTS AND APPEARANCE
    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)