FDA.reportPublic FDA data

Povi-One

Manufacturer
Elevate Oral Care
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:46:45

Label at a glance#

ProductPovi-One
Active ingredientPOVIDONE-IODINE
Label structure13 sections

Label contents#

Full prescribing information#

Drug Facts Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

Uses

OTC - PURPOSE SECTION

PurposePurpose

Warnings For External Use Do Not Use

WARNINGS SECTION

Do Not UseDo Not Use

Stop Use and Ask A Doctor

OTC - STOP USE SECTION

Stop UseStop Use

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 Panel

DOSAGE & ADMINISTRATION SECTION

Drug Facts PanelDrug Facts Panel

Povi-One Solution 0.2ml X 6 Ampules NDC: 57511-0610-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povi-OnePovi-One

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57511-0610-12024-12-11C16284748780-1e4f33bdf-b396-d8a0-e053-dadaa90a6e4ePove-One
57511-0610-12022-07-29C16284748780-1e4f33bdf-b396-d8a0-e053-dadaa90a6e4ePove-One

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-2325-16ML - Milliliter0395-232539b70cc0-6fd4-47db-8915-5fae5f0c09a112013-10-17
0395-2325-98ML - Milliliter0395-232507e02985-9105-4d4e-80c2-d37b859181ee12013-10-17

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57511-061057511-0610-1
0395-2325

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BIACT
POVIDONE-IODINE85H0HZU99MACTIM
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-2U4A966MO25IACT
WATER059QF0KO0RIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
347a4057-37fa-f5f2-e063-6294a90a423ed8ca1d1f-f945-480b-e053-2a95a90a096e2025-05-06WarningsExact identifier
spl set id: d8ca1d1f-f945-480b-e053-2a95a90a096e
Humco Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.1e078022-f32c-48bd-8add-f83aebcc58122024-12-18WarningsExact identifier
ndc (product): 0395-2325

Reported adverse events (FAERS/openFDA)#

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