Active Ingredient
Povidone iodine USP 10%
Povidone Iodine Prep Pad Swab
FDA Label NDC 67777-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Povidone Iodine Prep Pad (NDC 67777-002). 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, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - 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
- Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes and burns
- For preparation of the skin prior to surgery
- Helps reduce bacteria that can potentially cause skin infection
Warnings
For External Use Only
Do Not Use
- In the eyes
- As a first aid antiseptic for more than 1 week
- 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
- Condition worsens or persists for more than 72 hours
- Irritation or redness develops
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Directions
- Tear at notch
- Remove applicator
- Use only once
- 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 antiseptic
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 USP, Sodium Phosphate Dibasic, Water
* Please review the disclaimer below.
