POVIDONE-IODINE solution

POVIDONE-IODINE by

Drug Labeling and Warnings

POVIDONE-IODINE by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation, Acmne United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (each swab)

10% Povidone Iodine Solution USP, (1% available Iodine)

Purpose

Topical Antiseptic

Uses

First Aid Antiseptic To Help prevent infection in minor skin cuts and abrasions and burns.

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.

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.

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 Information

Store at room temperature away from light. Keep from freezing or excessive heat.

Inactive Ingredients

Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

Questions?

Call 1-800.835.2263

PRINCIPAL DISPLAY PANEL

carton label

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5408(NDC:46414-7777)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-5408-01	10 in 1 CONTAINER	06/30/2025
1	NDC: 0924-5408-00	0.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 0924-5408-02	100 in 1 CONTAINER	06/30/2025
2	NDC: 0924-5408-00	0.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/30/2025

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	repack(0924-5408) , relabel(0924-5408)

Establishment
Name	Address	ID/FEI	Business Operations
Acmne United Corporation		080119599	relabel(0924-5408) , repack(0924-5408)