Active Ingredient
Povidone Iodine USP 10%
w/v (equivalent to 1% titratable iodine).
Povidone Iodine Swabstick
FDA Label NDC 69396-187
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Povidone Iodine Swabstick (NDC 69396-187). 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, directions, ask doctor before use if you have, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antiseptic
Uses
Health care antiseptic for preparation of the skin prior to surgery.
First Aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns.
Warnings
For external Use Only
Do not use
- in eyes
- over large areas of the body
- on individuals who are allergic or sensitive to iodine
- as a first aid antiseptic longer than 1 week unless directed by a doctor
Directions
For preparation of the skin prior to surgery
- Clean the affected area
- Remove swab by stick
- Apply to the operative site prior to surgery
- Clean the affected area
- apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily.
- may be covered with a sterile bandage
- if bandaged let dry first
For use as a first aid antiseptic
Ask Doctor Before Use If You Have
- deep or puncture wounds
- animal bites
- serious burns
Inactive Ingredients
Citric Acid, Glycerin, Nonoxynol - 10, Sodium Hydroxide, Water
Questions?
Call 1-888-296-9067
Stop Use And Ask A Doctor If
- The condition persists or gets worse
- Irritation and redness develops
Storage Information
- Store at controlled room temperature 15° to 30°C (59°F to 86°F).
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Questions
1-888-296-9067
Other Information
Distributed By:
Trifecta Pharmaceuticals USA®
101 NE Third Ave. Ste 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
SKU: 4014-FBA
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