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%
Purpose
Antiseptic
Uses:
- First aid to help prevent skin 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 wounds
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.
As a first aid antispetic:
- Clean affected area
- Apply 1-3 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.
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
POVIDONE
IODINE
PREP PAD
Antiseptic
100 PADS
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