FDA.reportPublic FDA data

Povidone Iodine Prep

Manufacturer
Sion Biotext Medical Ltd
Effective date
2025-09-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:12:42

Label at a glance#

ProductPovidone Iodine Prep
Active ingredientPOVIDONE-IODINE
Label structure8 sections

Indications and uses

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

Dosage and administration

Tear at notch 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 bandaged, let dry first. For preoperative patient skin preparation Clean affected area Apply to operative site prior to surgery using applicator

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine  10% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION


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

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 than 1 week
  • Over large areas of the body


Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious wounds

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens or persists for more than 72 hours
  • Irritation and redness develops

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 immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Tear at notch
  • 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 bandaged, let dry first.

For preoperative patient skin preparation

  • Clean affected area
  • Apply to operative site prior to surgery using applicator



Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

  • Nonoxynol-9, water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVP Prep Solution

First Aid Antiseptic

NET WT. 0.75 oz

500 Packets per Case

Made in Israel

NDC 68786-132-01

Label 1Label 1

100 Packets per case

NDC 68786-132-02

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN5
312564povidone-iodine 100 MG/ML Topical SolutionSCD5
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY5

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
68786-132-012022-01-03C16284748780-19d75b9d0-45f7-f424-e053-dadaa90a57ceDrug Facts
68786-132-012020-01-31C16284748780-19d75b9d0-45f7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-132-01Povidone Iodine Prep22.18 mL in 1 PACKETSOLUTION22.185
68786-132-01Povidone Iodine Prep500 in 1 CASESOLUTION5005
68786-132-02Povidone Iodine Prep100 in 1 CASESOLUTION1005
68786-132-02Povidone Iodine Prep22.18 mL in 1 PACKETSOLUTION22.185

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
IODINEACTIVE MOIETY9679TC07X41
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68786-13268786-132-01, 68786-132-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
POLYSORBATE 806OZP39ZG8HIACT
GLYCERINPDC6A3C0OXIACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
CITRIC ACID2968PHW8QPIACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates

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
Povidone Iodine PrepPOVIDONE IODINESion Biotext Medical Ltde05af551-647d-4278-bb7f-86f888ddbb8b2025-09-04WarningsExact identifier
ndc (package): 68786-132-02
ndc (package): 68786-132-01
ndc (product): 68786-132
ndc11 (package): 68786013202
ndc11 (package): 68786013201
spl id: 3e014f0c-43e0-482e-e063-6294a90a44ce
spl set id: e05af551-647d-4278-bb7f-86f888ddbb8b

Reported adverse events (FAERS/openFDA)#

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