Povidone-iodine Solution
FDA Label NDC 37808-624

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Povidone-iodine (NDC 37808-624). 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 tamper evident statement, active ingredient, purpose, uses, warnings, do not use, ask a doctor before use, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Tamper Evident Statement

Do not use if seal under cap is broken or missing

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

Questions?

1-888-593-0593

Disclaimer

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Betadine ® Antiseptic 10% Povidone-iodine First Aid Antiseptic.

Adverse Reaction

MADE WITH PRIDE & CARE FOR H-E-B ®

SAN ANTONIO, TX 78204

100% GUARANTEE promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.

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Compare to Betadine ® 10% Povidone-iodine First Aid Antiseptic*

H-E-B ®

Povidone-Iodine Solution, 10%

First Aid Antiseptic

  • Helps prevent infection in minor cuts, scrapes, and burns

    • 8 FL OZ (237 mL)

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    Image Description (Mm01)

* Please review the disclaimer below.