Betadine Solution
FDA Label NDC 67618-150

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare, Inc. for the product Betadine (NDC 67618-150). 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 drug facts, purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient

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

Purpose

First aid antiseptic

Uses

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Do Not Use

  • in the eyes
  • over large areas of the body
  • if you are allergic to povidone-iodine or any other ingredients in this preparation

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop Use And Ask A Doctor If

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

Directions

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

Other Information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

citric acid, disodium phosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

Package Label.Principal Display Panel

Betadine Solution 8 fl oz Bottle
NDC: 67618-150-08

Betadine Solution Bottle (305541 0d)

Betadine Solution Bottle (305541 0d)

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