FDA.reportPublic FDA data

Povidone Iodine

Manufacturer
TwinMed LLC | Sion Biotext Mexico SAPI de CV
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:27:02

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Indications and uses

First aid to help prevent skin infection in minor cuts, scrapes, and burns Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.

Dosage and administration

Tear at notch. Remove applicator. Discard applicator after single use. As a first aid antispetic: Clean affected area Apply 1-3 times daily May be covered with a sterile bandage If bandaged, let dry first. For preoperative patient skin preparation Clean area Apply to operative site prior to surgery using applicator.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

  • First aid to help prevent skin infection in minor cuts, scrapes, and burns
  • Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.

Warnings:

WARNINGS SECTION

For external use only.

Do not use:

OTC - DO NOT USE SECTION

  • In the eyes
  • Longer than one week unless directed by a doctor
  • On individuals who are allergic or sensitive to iodine
  • Or apply 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

  • Irritation and redness develops
  • If condition persists for more than 72 hours, consult a physician.

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. Remove applicator. Discard applicator after single use.

As a first aid antispetic:

  • Clean affected area
  • Apply 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first.

For preoperative patient skin preparation

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

Other Information:

OTHER SAFETY INFORMATION

  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate UPS, Sodium Phosphate Dibasic, Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROCURE

HEALTHCARE PRODUCTS

POVIDONE

IODINE

PREP PAD

Antiseptic

100 PADS

L1L1

L2L2

L3L3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN3
797730povidone-iodine 100 MG/ML Medicated PadSCD3
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY3
797730povidone-iodine 10 % Medicated PadSY3
797730povidone-iodine 10 % Medicated SwabstickSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeDX Film Edge21-10Povidone Iodine Prep Pads (3).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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-751-00Povidone Iodine10 in 1 CASESWAB103
55681-751-00Povidone Iodine100 in 1 BOXSWAB1003

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
55681-75155681-751-00

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
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM
POLYSORBATE 806OZP39ZG8HIACT
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
Povidone IodinePOVIDONE-IODINETwinMed LLCfc8cb10c-4973-c0bd-e053-6394a90a6fdb2025-12-18WarningsExact identifier
ndc (package): 55681-751-00
ndc (product): 55681-751
ndc11 (package): 55681075100
spl id: 464779d4-ec67-e366-e063-6394a90a688c
spl set id: fc8cb10c-4973-c0bd-e053-6394a90a6fdb

Reported adverse events (FAERS/openFDA)#

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