FDA.reportPublic FDA data

Povi-One

Manufacturer
Elevate Oral Care
Effective date
2025-09-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:14:21

Label at a glance#

ProductPovi-One
Active ingredientPOVIDONE-IODINE
Label structure13 sections

Label contents#

Full prescribing information#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Drug Facts ActiveDrug Facts Active

Uses Purpose

OTC - PURPOSE SECTION

UsesUses

Warning For External Use Do Not Use

WARNINGS SECTION

WarningsWarnings

Stop Use And Ask a Doctor

OTC - STOP USE SECTION

Stop use and ask a DoctorStop use and ask a Doctor

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of ChildrenKeep out of reach of Children

Directions

INDICATIONS & USAGE SECTION

DirectionsDirections

Other Information

OTHER SAFETY INFORMATION

Other InformationOther Information

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

Contents

DESCRIPTION SECTION

ContentsContents

Questions?

OTC - QUESTIONS SECTION

Questions?Questions?

Instructions for Use

INSTRUCTIONS FOR USE SECTION

Instructions for UseInstructions for Use

Drug Facts Other Information

DOSAGE & ADMINISTRATION SECTION

Drug FactsDrug Facts

Povi-One Soultion Outside box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povi-One SolutionPovi-One Solution

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0611-1Povi-One6 mL in 1 BOX, UNIT-DOSELIQUID66

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57511-061157511-0611-1
68599-3500

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM CITRATE1Q73Q2JULRIACT
GLYCERINPDC6A3C0OXIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsExact identifier
ndc (product): 68599-3500
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Care27c29a33-d1cc-d72f-e063-6394a90a4d452025-09-19WarningsExact identifier
ndc (product): 57511-0611
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Caref5252b4f-5e14-509e-e053-2995a90a6db82025-09-18WarningsExact identifier
ndc (package): 57511-0611-1
ndc (product): 57511-0611
ndc11 (package): 57511061101
spl id: 3f1914a6-3095-23c3-e063-6294a90ac03a
spl set id: f5252b4f-5e14-509e-e053-2995a90a6db8

Reported adverse events (FAERS/openFDA)#

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