POVIDONE-IODINE
POVIDONE IODINE TOPICAL SOLUTION USP
37c709ae-ef37-0b46-e063-6394a90af861
HUMAN OTC DRUG LABEL
Jun 17, 2025
Acme United Corporation
DUNS: 001180207
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
POVIDONE-IODINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
carton label 
INDICATIONS & USAGE SECTION
Uses
First Aid Antiseptic To Help prevent infection in minor skin cuts and abrasions and burns.
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (each swab)
10% Povidone Iodine Solution USP, (1% available Iodine)
OTC - PURPOSE SECTION
Purpose
Topical Antiseptic
WARNINGS SECTION
Warnings
For external use only.
Do not use in the eyes; if you are allergic to any of the ingredients; longer than 1 week unless directed by a doctor.
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 SECTION
Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.Discard after single use.
OTHER SAFETY INFORMATION
Other Information
Store at room temperature away from light. Keep from freezing or excessive heat.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.
OTC - QUESTIONS SECTION
Questions?
Call 1-800.835.2263