Major Povidone Iodine

Manufacturer
Major Pharmaceuticals | Pharma Nobis, LLC
Effective date
2026-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-20 01:01:32

Label at a glance#

ProductPovidone-Iodine
Active ingredientPOVIDONE-IODINE
Label structure14 sections

Indications and uses

First aid antiseptic to prevent infection in minor cuts, scrapes and burns.

Dosage and administration

Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If bandaged, let it dry first.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid antiseptic to prevent infection in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For External Use Only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep puncture wounds
  • animal bites
  • serious burns

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • irritation and redness develop and persists for more than 72 hours

When using this product do not

OTC - WHEN USING SECTION

  • use in eyes
  • use on individuals who are allergic or sensitive to iodine or use for longer than 1 week unless directed by a doctor
  • apply over large areas of the body

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If bandaged, let it dry first.

Other information

OTHER SAFETY INFORMATION

store at room temperature, 20-25C (68-77F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified Water.

Questions & comments?

OTC - QUESTIONS SECTION

1-833-551-0932

Current Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR

NDC 0904-7639-54

Povidone-Iodine

Topical Solution

povidone-iodine 10%

First Aid Antiseptic

Helps Prevent Infection in Minor Cuts, Scrapes and Burns

COMPARE TO THE ACTIVE INGREDIENT IN BETADINE®†

8 FL OZ (237 mL)

*SAFETY SEALED

*Warning: Do not use if Tamper Evident Seal is broken or missing. This product is sealed with a foil seal under cap.

†This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Betadine®

Distributed by:

MAJOR PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Rev. 01/26 M-184 Re-order No. 701457

Major Povidone Iodine 8 13 2026Major Povidone Iodine 8 13 2026

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130309047639540GTIN-13: 0309047639540
EAN-13: 0309047639540
GTIN-12: 309047639540
UPC-A: 309047639540
GTIN storage (14 digits): 00309047639540
Major Povidone Iodine 8 13 2026.jpg

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-76390904-7639-54

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-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsExact identifier
ndc (package): 0904-7639-54
ndc (product): 0904-7639
ndc11 (package): 00904763954
spl id: 59041cb4-9e59-5d10-e063-6394a90a6b07
spl set id: 59041ca3-a195-5a20-e063-6394a90a2ac9

Reported adverse events (FAERS/openFDA)#

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