FDA Label for Povidone-iodine
View Indications, Usage & Precautions
Povidone-iodine Product Label
The following document was submitted to the FDA by the labeler of this product Medline Industries, Lp. 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.
Active Ingredient
Povidone-Iodine, 10% (equivalent to 1% available iodine)
Purpose
Antiseptic
Uses
■ Healthcare antiseptic for preparation of the skin prior to surgery
■ First aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Warnings
For external use only.
Do Not Use
■ in the eyes
■ longer than 1 week unless directed by a doctor
■ on individuals who are allergic or sensitive to iodine
■ or apply over large areas of the body
When Using This Product
■ prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
■ in pre-operative prepping, avoid “pooling” beneath the patient.
Stop Use And Ask A Doctor
■ if irritation and redness develop
■ if condition persists for more than 72 hours
■ in case of deep or puncture wounds, animal bites or serious burns.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Clean the affected area
- For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
- For first aid antiseptic: 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 at Room Temperature. Protect from freezing. Avoid excessive heat.
Inactive Ingredients
Citric Acid, Deionized Water, Glycerin, Polysorbate 80, Sodium Citrate, Sodium Phosphate Dibasic
Other
www.medline.com
Manufactured for: Medline Industries Inc., Northfield, IL 60093 USA
Made in Mexico To Order Call: 1-800-MEDLINE RK16DEG
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