Label: PREP SOLUTION - povidone-iodine solution
view more65517-0009-5, 65517-0009-6
- Packager: Dukal Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 1, 2010
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- PRINCIPAL DISPLAY PANEL
Povidone Iodine USP
10% Topical Solution
Distributed by Owens and Minor
Mechanicsville, VA 23116
- ACTIVE INGREDIENT
Povidone-Iodine 10% (equivalent to 1% available iodine)
Healthcare antiseptic for preparation of skin prior to surgery.
First Aid Antiseptic to help prevent infection in minor cuts scrapes and burns.Close
For external use only.Close
- DO NOT USE
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 area of the bodyClose
- STOP USE
Stop use and ask a doctor
If irritation and redness develop
If condition persists more than 72 hours
In case of deep or puncture wounds, animal bites or serious burns, consult a doctorClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.Close
- INDICATIONS & USAGE
Clean the affected area
For preparation of skin prior to surgery:
apply the 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.Close
- STORAGE AND HANDLING
Protect from freezing
Avoid excessive heatClose
- INACTIVE INGREDIENT
Citric Acid, Disodium Phosphate, Glycerin, Polysorbate 80, Sodium Citrate, WaterClose
- PVP Prep Label
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65517-0009 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE - UNII:FZ989GH94E, IODINE - UNII:9679TC07X4) POVIDONE-IODINE 1.20 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65517-0009-1 59 mL in 1 BOTTLE 2 NDC:65517-0009-2 59 mL in 1 BOTTLE, SPRAY 3 NDC:65517-0009-3 118 mL in 1 BOTTLE 4 NDC:65517-0009-4 237 mL in 1 BOTTLE 5 NDC:65517-0009-5 473 mL in 1 BOTTLE 6 NDC:65517-0009-6 946 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 01/01/2010 Labeler - Dukal Corporation (791014871)