FDA Label for Povidone Iodine
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- DO NOT
- DISCONTINUE USE AND ASK A DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- ASK A DOCTOR IN CASE OF
- OTC - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTC - QUESTIONS
- LABEL INFORMATION
Povidone Iodine Product Label
The following document was submitted to the FDA by the labeler of this product Kmart Corporation. 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 USP, 10% w/v (equivalent to 1% titratable iodine)
Purpose
Antiseptic
Use
First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns
Warnings
For external use only.
Do Not
- use in the eyes
- use on individuals who are allergic or sensitive to iodine
- apply over large areas of the body
Discontinue Use And Ask A Doctor
- if condition persists or gets worse
- for use longer than 1 week
Otc - Ask Doctor/Pharmacist
Otc - When Using
Ask A Doctor In Case Of
- deep or puncture wounds
- animal bites
- serious burns
Otc - Pregnancy Or Breast Feeding
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean the affected area
- Apply a small amount of this product to the area 1-3 times daily
- May be covered with a sterile bandage
- If bandaged, let dry first
Other
Other Information
Store at room temperature 15° - 30° C (59° - 86° F)
Inactive Ingredients
Citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide
Otc - Questions
Label Information
Compare to active ingredient of Betadine® Solution*
NDC 49738-050-34
AMERICAN FARE
POVIDONE-
IODINE
SOLUTION
- First Aid Antiseptic
- Kills germs in minor burns, cuts and scrapes
*This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.
If you are not completely satisfied with this or any American Fare product, please call 1-800-842-7886.
Distributed by:
Kmart Corporation
Hoffman Estates, IL 60179
Made in USA
* Please review the disclaimer below.