FDA.reportPublic FDA data

CR-5667761, NDC 70000-0060-1

Manufacturer
Cardinal Health | Dynarex Corporation
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-10 01:03:28

Label at a glance#

ProductLeader Povidone-Iodine 10% Topical 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#

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 (1-800-222-1222) right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid Anhydrous, Disodium Phosphate Anhydrous, Glycerin, Polysorbate 80, Puried Water, Sodium Citrate USP

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

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 15º-30ºC (59º-86ºF).

Questions?

OTC - QUESTIONS SECTION

1-888-396-2739

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CR-5667761 IN MasterCR-5667761 IN Master

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295140156GTIN-13: 0096295140156
EAN-13: 0096295140156
GTIN-12: 096295140156
UPC-A: 096295140156
GTIN storage (14 digits): 00096295140156		CR-5667761 IN MASTER.jpg

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0060-1ML - Milliliter70000-0060fda308d7-4327-4c14-99b2-89e915757dc512022-02-07

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
70000-006070000-0060-1

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
POVIDONE-IODINE85H0HZU99MACTIM
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM CITRATE1Q73Q2JULRIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-11-25full-release2026-06-01 01:18:08

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
Leader Povidone-Iodine 10% Topical SolutionPOVIDONE IODINE PREP SOLUTION 10%Cardinal Healthb023e2e3-a4af-eb19-e053-2995a90a7c6e2025-11-25WarningsExact identifier
ndc (package): 70000-0060-1
ndc (product): 70000-0060
ndc11 (package): 70000006001
spl set id: b023e2e3-a4af-eb19-e053-2995a90a7c6e

Reported adverse events (FAERS/openFDA)#

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