Otc - Active Ingredient
Active Ingredients (each swab)
10% povidone Iodine solution USP
Active Ingredients (each swab) 10% povidone Iodine solution USP
Povidone-iodine Solution
FDA Label NDC 46414-7777
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by James Alexander Corporation for the product Povidone-iodine (NDC 46414-7777). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose 1% available iodine topical antiseptic
Purpose (1% available iodine) topical antiseptic
Indications & Usage
Uses to treat minor skin cuts and abrasions
Uses to treat minor skin cuts and abrasions
Warnings
Warnings for external use only
Warnings for external use only
Otc - Ask Doctor
Ask a doctor before use if you have deep or punction wounds seiour burns stop use and ask a doctor if redness irration swelling or pain persists or increases infection occurs
Ask a doctor before use if you have deep or puncture wounds serious burns stop use and ask a doctor if redness irritation swelling or pain persists or increases infection occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help immediately or contact a Poison Control Center right away
Keep out of reach of children. If swallowed get medical help immediately or contact a Poison Control Center right away.
Dosage & Administration
Directions reverse cardboard sleeve then crush at dot between thumb and forefinger. allow solution to saturate tip and apply solution to injury
Directions reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury
Other Safety Information
Other information Store at room temperature away from light. Keep from freezing or excessive heat.
Other Information store at room temperature away from light. Keep from freezing or excessive heat.
Inactive Ingredient
Inactive Ingredients citric acid, disodium phosphate, nonoxynol 9 sodium hydroxide water
Inactive Ingredients Citric Acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
Otc - Questions
Questions ? Call 1-908-362-9266 monday through friday, 9:00am to 5:00pm e.s.t.
Questions ? Call 1-908-363-9266 Monday through Friday, 9:00am to 5:00pm e.s.t.
Package Label.Principal Display Panel
Reorder No 771 100 swabs Povidone Iodine Topical Solution USP 0.02 fl. oz. (0.6 ml) each dispensing solutions
James Alexander Corportion
Blairstown, NJ 908-362-9266 Product Information and MSDS available online at www.james-alexander.com
ANSI Z308.1-2003 Reorder No. 773
Povidone Iodine Topical Solution USP Swabs 10 swabs 0.02 fl. oz. (0.6 ml) each dispensing solutions
James Alexander Corporation Blairstown, NJ 908-362-9266 Product Information and MSDS availabel online at www.james-alexander.com
* Please review the disclaimer below.
