Active Ingredient
Povidone-Iodine 10% (equivalent to 1% titrable Iodine)
Povidone Iodine Prep Solution
FDA Label NDC 68786-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd for the product Povidone Iodine Prep (NDC 68786-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warning, do not use:, ask a doctor before use if:, stop use and ask a doctor if:, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Label (89)
* Please review the disclaimer below.
