FDA Label for Povidone Iodine Prep
View Indications, Usage & Precautions
Povidone Iodine Prep Product Label
The following document was submitted to the FDA by the labeler of this product Sion Biotext Medical Ltd. 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 to 1% titrable Iodine)
Purpose
Antiseptic
Uses
- First Aid for minor cuts, scrapes, and burns (helps prevent infection)
- Preoperative skin prep (reduces bacteria)
Warning
For external use only.
Do Not Use:
- In eyes
- More than week (unless advised by a doctor)
- On those allergic/senstiive to iodine
- Over large body areas
Ask A Doctor Before Use If:
- Deep or puncure wounds.
- Animal Bites
- Serious wounds
Stop Use And Ask A Doctor If:
- Irritation or redness appears
- Condition lasts more than 72 hours
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Directions
As a first aid antiseptic:
- Clean affected area
- Apply a fingertip-sized amount 1-3 tmes daily
- Cover with a sterile bandage if desired (allow to dry first)
- Clean area
- Apply before surgery
- Let dry at least 2 minutes before draping
- Remove soiled underdrapes
- Avoid pooling
For preoperative patient skin preparation:
Other Information
- Store at room temperature 20-25° C (68-77°F)
- Avoid excessive heat
- Not made with natural rubber latex
Inactive Ingredients
Citric acid, dibasic sodium phosphate, glycerin, polysorbate 80 (tween 80), sodium citrate, water.
Package Label.Principal Display Panel
NDC 68786-010-89
SIONBIOTEXT
Prep Solution Topical Antiseptic Microbicide
10% POVIDONE IODINE
NET CONTENT
3 fl.oz. (89 ml)
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