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 Twinmed Llc. 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 1% titratable Iodine)
Purpose
Antiseptic
Uses:
- First aid to help prevent infection in minor cuts, scrapes and burns
- Patient preoperative skin preparation.Helps to reduce bacteria that potentially can cause skin infection.
Warnings:
For external use only.
Do Not Use:
- In the eyes
- Longer than one week unless directed by a doctor
- On individuals who are allergic or sensitive to iodine
- Or apply over large areas of the body
Ask A Doctor Before Use If You Have:
- Deep or puncture wounds
- Animal bites
- Serious burns
Stop Use And Ask A Doctor If:
- Irritation and redness develops
- If condition persists for more than 72 hours, consult a physician.
Keep Out Of Reach Of Children:
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions:
- Tear at notch
- Remove applicator
- Discard applicator after single use.
- Clean affected area
- Apply 1 to 3 times daily.
- May be covered with a sterile bandage
- If bandaged, let dry first.
- Clean area
- Apply to operative site prior to surgery using applicator.
As a first aid antispetic
For preoperative patient skin preparation:
Other Information:
- Store at room temperature
- Avoid excessive heat
Inactive Ingredients:
Citric Acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate UPS, Sodium Phosphate Dibasic, Water
Principal Display Panel
PROCURE
HEALTHCARE PRODUCTS
Triple Pack
POVIDONE IODINE
SWABSTICKS
Antiseptic
25 Swabsticks Per Box
10 Boxes Per Case
250 Swabstick Packs Total
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