FDA.reportPublic FDA data

Povidone Iodine

Manufacturer
Humco Holding Group, Inc. | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:04:36

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure28 sections

Dosage and administration

Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If badaged, let it dry first.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 10%

(1% available iodine)

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Use

INDICATIONS & USAGE SECTION

First aid antiseptic to prevent infection in minor cuts and burns.

Warnings

WARNINGS SECTION

For External Use Only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep punture wounds
  • animal bites
  • serious burns

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • irritation and redness develop and persits for more than 72 hours

When using this product do not

OTC - WHEN USING SECTION

  • use in eyes
  • use on individuals who are allergic or sensitive to iodine or use for longer thn 1 week unless directed by a doctor
  • apply over large areas of the body

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If badaged, let it dry first.

Other information

OTHER SAFETY INFORMATION

store at room temperature, 20-25C (68-77F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified Water.

Sunmark Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 fl oz

SM 8SM 8

16 fl oz

SM 16SM 16

Good Neighbor Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPPov.jpgGNPPov.jpgGNPGNP

Leader Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LDRPov.jpgLDRPov.jpgLeaderLeader

Quality Choice Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QCPov.jpgQCPov.jpgQCQC

Select Brand Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SBSB

Publix Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PublixPublix

Premier Value Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVPV

Fred's Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FredsFreds

DDM Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DDMDDM

Rite Aid Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RAPov.jpgRAPov.jpgRARA

CVS Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSCVS

Vida MIaa Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VMVM

HEB Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEBHEB

Health Mart Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HMPov.jpgHMPov.jpgHMHM

Purdue Betadine Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Purdue Betadine 10.jpgPurdue Betadine 10.jpg

Top Care Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Care PovidoneTop Care PovidoneTCPov.jpgTCPov.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN7
312564povidone-iodine 100 MG/ML Topical SolutionSCD7
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9123-16Povidone Iodine473 mL in 1 BOTTLE, PLASTICLIQUID4737
0395-9123-98Povidone Iodine237 mL in 1 BOTTLE, PLASTICLIQUID2377

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9123POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [HUMCO HOLDING GROUP, INC.]7Current NDC, Legacy NDC, 2 package rows20231216_6064c23b-7c15-208d-e053-2991aa0a00f6.zip

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
0395-91230395-9123-98, 0395-9123-16

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

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
Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.6064c23b-7c15-208d-e053-2991aa0a00f62023-12-15WarningsExact identifier
ndc (package): 0395-9123-16
ndc (package): 0395-9123-98
ndc (product): 0395-9123
ndc11 (package): 00395912398
ndc11 (package): 00395912316
spl id: 0c936cb3-8393-0603-e063-6394a90a0640
spl set id: 6064c23b-7c15-208d-e053-2991aa0a00f6

Reported adverse events (FAERS/openFDA)#

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