FDA Label for Betadine Solution Swabsticks
View Indications, Usage & Precautions
Betadine Solution Swabsticks Product Label
The following document was submitted to the FDA by the labeler of this product Atlantis Consumer Healthcare, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient Purpose
Povidone-iodine Solution USP, 10% (equal to 1% available iodine)
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
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