FDA.reportPublic FDA data

POVIDONE IODINE SURGICAL SCRUB

Manufacturer
Biotronix Healthcare Industries, Inc.
Effective date
2018-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:26

Label at a glance#

ProductPOVIDONE IODINE SURGICAL SCRUB
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Povidone Iodine 10%

OTC - PURPOSE SECTION

Purpose
Antiseptic

WARNINGS SECTION

Warnings
For external use only. Do not use in the eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if Skin shows symptons of irritation, sensitivity, redness, pain or swelling

DOSAGE & ADMINISTRATION SECTION

Direction

  • Wet hands and forearms with water
  • Clean under nails with nail cleaner
  • Scrub for 3 minutes with the impregnated brush
  • Pay close attention to the nails, cuticles, and interdigital spaces
  • Rinse thoroughly with running water
  • Repeat

INACTIVE INGREDIENT SECTION

Inactive ingredients

Hydroxyethylcellulose, Nonoxynol ethoxylate, Purified Water

INDICATIONS & USAGE SECTION

Uses For cleansing hands and arms prior to surgery

OTHER SAFETY INFORMATION

Other information

  • Store at room temperature
  • Avoid excessive heat above 40 °C (104 °F)
  • Protect from freezing
  • Latex free

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of package labelimage of package label

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
71389-102-012020-01-31C16284748780-19d75b9d0-d48f-f424-e053-dadaa90a57ce6b89fcf5-5a52-7e20-e053-2a91aa0a08fc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71389-102-01POVIDONE IODINE SURGICAL SCRUB20 mL in 1 POUCHSPONGE201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71389-102POVIDONE IODINE SURGICAL SCRUB (POVIDONE IODINE) SPONGE [BIOTRONIX HEALTHCARE INDUSTRIES, INC.]1Legacy NDC, 1 package rows20180506_6b89fcf5-5a52-7e20-e053-2a91aa0a08fc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71389-10271389-102-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
WATER059QF0KO0RIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
NONOXYNOL-10K7O76887APIACT

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
6b89fcf5-5a51-7e20-e053-2a91aa0a08fc6b89fcf5-5a52-7e20-e053-2a91aa0a08fc2018-05-06WarningsExact identifier
spl id: 6b89fcf5-5a51-7e20-e053-2a91aa0a08fc
spl set id: 6b89fcf5-5a52-7e20-e053-2a91aa0a08fc

Reported adverse events (FAERS/openFDA)#

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