Active Ingredient
Active Ingredient Purpose
Povidone Iodine 10% v/v Antiseptic
Povidone Iodine Solution
FDA Label NDC 0904-1103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Povidone Iodine (NDC 0904-1103). 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, uses, warnings, do not use, ask a doctor before use if you have, stop use, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
- Healthcare antiseptic for preparation of the skin prior to surgery.
- Antiseptic cleanser for preparation of skin prior to an infection.
Warnings
- FOR EXTERNAL USE ONLY
Do Not Use
- As a first aid antiseptic for more than 1 week unless directed by a doctor.
- In the eyes.
- Over large areas of the body.
- On individuals who are allergic or sensitive to iodine.
Ask A Doctor Before Use If You Have
- Deep puncture wounds
- Animal bites
- Serious burns
Stop Use
- If irritation and redness develop
- If condition persists for more than 72 hours, consult a physician.
Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.
Directions
As a first aid antiseptic
- clean affected area
- apply a small amount of this product to the area1 to 3 times daily
- may be covered with a sterile bandage, if bandaged let dry.
- clean area
- apply to operative site prior to surgery using the applicator
For preoperative patient skin preparation
Inactive Ingredient
- citric acid
- glycerin
- sodium citrate
- tween 80
- disodium phosphate
- purified Water
Principal Display Panel
NDC 0904-1103-09
Distributed by
Major Pharmaceuticals
Livonia, MI 48150 USA
Povidine Iodine Topical 10% Solution
8 Fl Oz. (236 mL)
* Please review the disclaimer below.
