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, 7.5% (equivalent to 0.75% available iodine)
Purpose
Antiseptic
Uses
■ For preparation of the skin prior to surgery
■ helps to reduce bacteria that potentially can cause skin infection
■ significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
Warnings
For external use only.
Do Not Use
■ in the eyes
■ if you are allergic to iodine or any of the other ingredients in the product.
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
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Surgical Hand Scrub: ■ Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. ■Wet hands and forearms ■ Apply 5 milliliters (teaspoonful) or palmful to hands and forearms ■ Scrub thoroughly for about 5 minutes paying particular attention to the nails, cuticles, and interdigital spaces ■ Use a sterile scrub brush, if desired ■ Rinse and repeat scrub
Patient Pre-operative Skin Preparation: ■ Prior to surgery, wet skin with water ■ Apply scrub to the operative site ■ scrub thoroughly for about 5 minutes ■ Rinse using sterile gauze or towel, or remove with 70 percent alcohol ■ follow with application of Medline Prep Solution and allow to dry
Other Information
Store at Room Temperature. Protect from freezing. Avoid excessive heat.
Inactive Ingredients
Disodium Phosphate, Glycerin, Hydroxy Ethyl Cellulose, Monoethanolamine, Water
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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