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 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 to 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% (equivalent 1% titratable Iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

  • First aid to help prevent 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 burns

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 to 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

Triple Pack

POVIDONE IODINE

SWABSTICKS

Antiseptic

25 Swabsticks Per Box

10 Boxes Per Case

250 Swabstick Packs Total

66

55

44

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

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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-753-00Povidone Iodine10 in 1 CASESWAB103
55681-753-00Povidone Iodine25 in 1 BOXSWAB253

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
55681-75355681-753-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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 LLCfcf30b3a-c25b-7aaf-e053-6394a90affda2025-12-18WarningsExact identifier
ndc (package): 55681-753-00
ndc (product): 55681-753
ndc11 (package): 55681075300
spl id: 46477c53-e5ff-d33f-e063-6394a90a2fbd
spl set id: fcf30b3a-c25b-7aaf-e053-6394a90affda

Reported adverse events (FAERS/openFDA)#

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