FDA.reportPublic FDA data

Dynarex Povidone Iodine Surgical Scrub

Manufacturer
Dynarex Corporation
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:22

Label at a glance#

ProductDynarex Povidone Iodine Surgical Scrub
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and uses

Surgical hand scrub which significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care. Preoperative skin preparation for the preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Dosage and administration

Surgical hand scrub: Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for five minutes paying particular attention to the nails, cuticles, and interdigital spaces. Rinse and repeat scrub. Preoperative skin preparation: Clean the area. Apply product to the operati...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine 7.5%

Purpose

OTC - PURPOSE SECTION

Healthcare Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Surgical hand scrub which significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
  • Preoperative skin preparation for the 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

  • Surgical hand scrub: Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for five minutes paying particular attention to the nails, cuticles, and interdigital spaces. Rinse and repeat scrub.
  • Preoperative skin preparation: 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

14251425

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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-142-50Dynarex Povidone Iodine Surgical Scrub473 mL in 1 BOTTLELIQUID4734
67777-142-51Dynarex Povidone Iodine Surgical Scrub24 in 1 CASELIQUID244
67777-142-60Dynarex Povidone Iodine Surgical Scrub3790 mL in 1 BOTTLELIQUID37904
67777-142-61Dynarex Povidone Iodine Surgical Scrub4 in 1 CASELIQUID44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-142DYNAREX POVIDONE IODINE SURGICAL SCRUB (POVIDONE IODINE SURGICAL SCRUB SOLUTION) LIQUID [DYNAREX CORPORATION]4Current NDC, Legacy NDC, 4 package rows20241122_6f053e55-cbf6-9072-e053-2991aa0a2edd.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
67777-14267777-142-50, 67777-142-51, 67777-142-60, 67777-142-61

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
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
MONOETHANOLAMINE5KV86114PTIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact identifier
ndc (package): 67777-142-51
ndc (package): 67777-142-61
ndc (package): 67777-142-50
ndc (package): 67777-142-60
ndc (product): 67777-142
ndc11 (package): 67777014261
ndc11 (package): 67777014250
ndc11 (package): 67777014260
ndc11 (package): 67777014251
spl id: 275871a0-3174-c7fa-e063-6394a90ac014
spl set id: 6f053e55-cbf6-9072-e053-2991aa0a2edd

Reported adverse events (FAERS/openFDA)#

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