FDA.reportPublic FDA data

PRO PH Filler

Manufacturer
PROTOX Inc.
Effective date
2016-11-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:00

Label at a glance#

ProductPRO PH Filler
Active ingredientHYALURONIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

crosslinked hyaluronic acid dermal filler

INACTIVE INGREDIENT SECTION

PLLA, Lidocaine

OTC - PURPOSE SECTION

n/a

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

Confirm the validity of the product label

to make sure the sterilizatios is not damaged before using

DOSAGE & ADMINISTRATION SECTION

N/A

INDICATIONS & USAGE SECTION

N/A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product labelproduct label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71066-0002-12020-01-31C16284748780-19d75b9d0-ba19-f424-e053-dadaa90a57ce4152de40-e1cb-653d-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71066-0002-1PRO PH Filler10 mL in 1 VIALGEL101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71066-0002PRO PH FILLER (HYALURONIC ACID) GEL [PROTOX INC.]1Legacy NDC, 1 package rows20161116_4152de40-e1cb-653d-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71066-000271066-0002-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987IACT
LACTIC ACID33X04XA5ATIACT
HYALURONIC ACIDS270N0TRQYACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4152de40-e1cc-653d-e054-00144ff88e884152de40-e1cb-653d-e054-00144ff88e882016-11-15WarningsExact identifier
spl id: 4152de40-e1cc-653d-e054-00144ff88e88
spl set id: 4152de40-e1cb-653d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.