Povidone Iodine Solution First Aid Antiseptic Solution
FDA Label NDC 11344-050

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Povidone Iodine Solution First Aid Antiseptic (NDC 11344-050). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Povidone-iodine, 10% (1% available iodine)

Purpose

First aid antiseptic

Uses

first aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Do Not Use

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask A Doctor Before Use

in case of deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If

condition persists or gets worse

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first.

Other Information

store between 15° - 30°C (59°-86°F)

Inactive Ingredients

 C12-13 Pareth-9, citric acid, disodium phosphate, glycerin, sodium hydroxide, water

Disclaimer

*This product is not manufactured or distributed by the Purdue Products L.P., distributor of Betadine ® First Aid Solution 10% Povidone-iodine Topical Solution.

Adverse Reaction

Distributed by:

Vi-Jon, LLC

St. Louis, MO 63114

Principal Display Panel

Swan ®

POVIDONE-IODINE SOLUTION 10%

FIRST AID ANTISEPTIC

  • Helps prevent infection in minor cuts, scrapes and burns

    • Compare to Betadine ®*

    4 FL OZ (118 mL)

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.