FDA.reportPublic FDA data

Povidone Iodine

Manufacturer
Rapid Care, Inc
Effective date
2021-10-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:17

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Indications and uses

First Aid Antiseptic to help prevent infection in minor cuts, scrapes or burns For preparation of the skin prior to surgery Helps reduce bacteria that can potentially cause skin infections

Dosage and administration

Tear at notch Remove applicator Use only once As a first aid antiseptic. clean affected area apply 1 to 3 times daily may be covered with a sterile bandage if bandage, let dry first

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10% (equivalent to 1% titratable iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • First Aid Antiseptic to help prevent infection in minor cuts, scrapes or burns
  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that can potentially cause skin infections

Warnings

WARNINGS SECTION

For external use only

Do Not Use

OTC - DO NOT USE SECTION

  • in the eyes
  • as a first aid antiseptic for more that 1 week
  • over large areas of the body

Ask a doctor in case of

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • if irritation and redness develop.
  • condition worsens or persists for more thatn 72 hours.

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

  • Tear at notch
  • Remove applicator
  • Use only once

As a first aid antiseptic. clean affected area

  • apply 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandage, let dry first

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature
  • Avoid excessive heat

Inactive ingredient

INACTIVE INGREDIENT SECTION

Nonoxynol-9, water

RapidCare - Providone Iodine - 1pc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povidone Iodine pouchPovidone Iodine pouch

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
73659-008-012023-01-30C16284748780-1f386c64a-1c6d-0266-e053-dadaa90a7c1aRapidCare - Povidone Iodine - 1pc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73659-008-01Povidone Iodine1 in 1 PACKETSWAB12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73659-008POVIDONE IODINE SWAB [RAPID CARE, INC]2Legacy NDC, 1 package rows20211016_b66aeafe-c31e-307c-e053-2995a90a824c.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73659-00873659-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
WATER059QF0KO0RIACT
NONOXYNOL-948Q180SH9TIACT

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
ce58d4e2-38b0-f9c8-e053-2a95a90a2567b66aeafe-c31e-307c-e053-2995a90a824c2021-10-14WarningsExact identifier
spl id: ce58d4e2-38b0-f9c8-e053-2a95a90a2567
spl set id: b66aeafe-c31e-307c-e053-2995a90a824c

Reported adverse events (FAERS/openFDA)#

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