FDA.reportPublic FDA data

Povidone Iodine

Manufacturer
Custom Kits Company Inc | James Alexander Corporation
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:02:58

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Dosage and administration

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply soltion to injury.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

10% Povidone Iodine Solution USP (1% available iodine)

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic

Directions

INDICATIONS & USAGE SECTION

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply soltion to injury.

Warnings

WARNINGS SECTION

  • For External Use Only

Ask a Doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

Deep or puncture wounds

Serious Burns

Stop Use

OTC - STOP USE SECTION

redness, irritation, swelling or pain persists or increases

infection occurs

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature away from light keep from freezing or excessive heat

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povidone Iodine SwabPovidone Iodine Swab

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN4
797730povidone-iodine 100 MG/ML Medicated PadSCD4
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY4
797730povidone-iodine 10 % Medicated PadSY4
797730povidone-iodine 10 % Medicated SwabstickSY4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68183-116-012022-01-28C16284748780-1d6a99b39-ba19-a426-e053-dadaa90af4c2Povidone Iodine Swabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68183-116-01Povidone Iodine10 mL in 1 BOX, UNIT-DOSESWAB104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68183-116POVIDONE IODINE SWAB [CUSTOM KITS COMPANY INC]4Legacy NDC, 1 package rows20200118_21fda613-cc35-34c8-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
IODINEACTIVE MOIETY9679TC07X41
WATERINACTIVE INGREDIENT059QF0KO0R1

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
68183-11668183-116-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
9c5ae6c8-2fb5-858b-e053-2995a90a53f521fda613-cc35-34c8-e054-00144ff88e882020-01-17WarningsExact identifier
spl id: 9c5ae6c8-2fb5-858b-e053-2995a90a53f5
spl set id: 21fda613-cc35-34c8-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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