FDA.reportPublic FDA data

Povidone Iodine

Manufacturer
Trifecta Pharmaceuticals USA LLC | Trifecta Pharmaceuticals USA
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:07

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure14 sections

Indications and uses

First Aid to help prevent infection in minor cuts, scrapes and burns.

Dosage and administration

Clean the affected area apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily. may be covered with a sterile bandage

Storage and handling

Store at controlled room temperature 20º to 25ºC (68ºF to 77ºF). close cap tightly after use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine USP 10%

w/w (available iodine 1%)

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

First Aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external Use Only

Do not use

  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily.
  • may be covered with a sterile bandage

Ask Doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Polyethylene glycol 400, Polyethylene glycol 4000

Questions?

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Stop Use and Ask a doctor if

OTC - STOP USE SECTION

  • The condition persists or gets worse
  • you need to use this product for more than 1 week

Storage Information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 20º to 25ºC (68ºF to 77ºF).
  • close cap tightly after use.

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 (1-800-222-1222) right away.

Questions

OTC - QUESTIONS SECTION

1-888-296-9067

Other Information

SPL UNCLASSIFIED SECTION

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

globe povidone iodine ointment 1oz CDERglobe povidone iodine ointment 1oz CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312563povidone-iodine 10 % Topical OintmentPSN2
312563povidone-iodine 0.1 MG/MG Topical OintmentSCD2
312563povidone-iodine 10 % (equal to 1 % available iodine) Topical OintmentSY2
312563povidone-iodine 10 % Topical OintmentSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-112-20Povidone Iodine1 in 1 BOXOINTMENT12
69396-112-20Povidone Iodine28.3 g in 1 TUBEOINTMENT28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-112POVIDONE IODINE (POVIDONE IODINE 10%) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20241222_f80ccd8a-9b9b-bbf9-e053-6394a90ac827.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-11269396-112-20

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
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT

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 IODINE 10%Trifecta Pharmaceuticals USA LLCf80ccd8a-9b9b-bbf9-e053-6394a90ac8272024-12-20WarningsExact identifier
ndc (package): 69396-112-20
ndc (product): 69396-112
ndc11 (package): 69396011220
spl id: 29b3ae6b-a09b-f62c-e063-6294a90a150b
spl set id: f80ccd8a-9b9b-bbf9-e053-6394a90ac827

Reported adverse events (FAERS/openFDA)#

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