Drug Facts
Active Ingredient Purpose
Povidone-iodine Solution USP, 10% (equal to 1% available iodine)
Betadine Solution
FDA Label NDC 67618-153
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 67618-153). 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, warnings, do not use this product, when using this product, stop using this product, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
- for preparation of the skin prior to surgery
- helps reduce bacteria that can potentially cause skin infection
Warnings
For external use only
Do Not Use This Product
- in the eyes
- if you are allergic to iodine or other product ingredients
When Using This Product
- prolonged exposure may cause irritation or, rarely, severe skin reactions
Stop Using This Product
- in rare instances of local irritation or sensitivity
- if irritation and redness develop and continue for more than 72 hours
Directions
- tear at slit; pull top of packette across, exposing end of swabstick
- remove Betadine Solution Swabstick and apply as needed
- use one time only
Other Information
- store between 20°-25°C (68°-77°F)
- Avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredients
citric acid, disodium phosphate, nonoxynol-9, purified water, sodium hydroxide
* Please review the disclaimer below.
