FDA.reportPublic FDA data

Dynarex Povidone Iodine Prep Solution

Manufacturer
Dynarex Corporation
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:38:22

Label at a glance#

ProductDynarex Povidone Iodine Prep Solution
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Dosage and administration

Clean the area. Apply product to the operative site prior to surgery.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine 10%

Purpose

OTC - PURPOSE SECTION

Healthcare Antiseptic

Use

INDICATIONS & USAGE SECTION

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Warnings

WARNINGS SECTION

For external use only

Do Not Use

OTC - DO NOT USE SECTION

  • if allergic to iodine
  • in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the area. Apply product to the operative site prior to surgery.

Other

OTHER SAFETY INFORMATION

Store at controlled room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80

Questions?

OTC - QUESTIONS SECTION

1-888-DYNAREX

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1413 Label1413 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN6
312564povidone-iodine 100 MG/ML Topical SolutionSCD6
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY6

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-141-30Dynarex Povidone Iodine Prep Solution118 mL in 1 BOTTLELIQUID1186
67777-141-31Dynarex Povidone Iodine Prep Solution48 in 1 CASELIQUID486
67777-141-40Dynarex Povidone Iodine Prep Solution237 mL in 1 BOTTLELIQUID2376
67777-141-41Dynarex Povidone Iodine Prep Solution24 in 1 CASELIQUID246
67777-141-50Dynarex Povidone Iodine Prep Solution473 mL in 1 BOTTLELIQUID4736
67777-141-51Dynarex Povidone Iodine Prep Solution24 in 1 CASELIQUID246
67777-141-60Dynarex Povidone Iodine Prep Solution3790 mL in 1 BOTTLELIQUID37906
67777-141-61Dynarex Povidone Iodine Prep Solution4 in 1 CASELIQUID46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-141DYNAREX POVIDONE IODINE PREP SOLUTION (POVIDONE IODINE PREP SOLUTION) LIQUID [DYNAREX CORPORATION]6Current NDC, Legacy NDC, 8 package rows20241122_6bb4d55b-2be7-3549-e053-2a91aa0a2bb0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-141-31ML - Milliliter67777-1416776f5bf-09a0-4555-83c8-8fe5e074887212025-11-13

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
67777-14167777-141-30, 67777-141-31, 67777-141-40, 67777-141-41, 67777-141-50, 67777-141-51, 67777-141-60, 67777-141-61

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
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM PHOSPHATESE337SVY37IACT
SODIUM CITRATE1Q73Q2JULRIACT
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
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
ndc (package): 67777-141-41
ndc (package): 67777-141-51
ndc (package): 67777-141-50
ndc (package): 67777-141-60
ndc (package): 67777-141-31
ndc (package): 67777-141-40
ndc (package): 67777-141-61
ndc (package): 67777-141-30
ndc (product): 67777-141
ndc11 (package): 67777014131
ndc11 (package): 67777014140
ndc11 (package): 67777014151
ndc11 (package): 67777014130
ndc11 (package): 67777014150
ndc11 (package): 67777014161
ndc11 (package): 67777014160
ndc11 (package): 67777014141
spl id: 275871a0-3173-c7fa-e063-6394a90ac014
spl set id: 6bb4d55b-2be7-3549-e053-2a91aa0a2bb0

Reported adverse events (FAERS/openFDA)#

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