IODINE PREP PAD ANTISEPTIC- povidone-iodine solution

Iodine Prep Pad Antiseptic by

Drug Labeling and Warnings

Iodine Prep Pad Antiseptic by is a Otc medication manufactured, distributed, or labeled by Yiwu Ori-Power Medtech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Povidone Iodine 10% USP.

Purpose

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Inactive Ingredients

Citric Acid, Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water.

Use

Topical Antimicrobial Agent For Wound Disinfection.

Directions

Tear open packet, use Iodine-saturated pad to cleanse desired skin area. Discard pad appropriately after use.

Storage

Store at room temperature 15°C - 30°C (59°F - 86°F).

Warnings

Avoid contact with eyes. If happens, rinse thoroughly with water. For External Use Only. If pain, irritation, redness, swelling, or infection develops, discontinue use and consult physician.

Keep Out  Of Reach Of Children

In case of accidental swallowing, seek medical help and contact poison control immediately.

Package Labeling:

INGREDIENTS AND APPEARANCE

IODINE PREP PAD ANTISEPTIC 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72459-283
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.BETA.-D-GLUCOPYRANOSE (UNII: J4R00M814D)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72459-283-00	0.55 g in 1 POUCH; Type 0: Not a Combination Product	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	02/01/2024

Labeler - Yiwu Ori-Power Medtech Co.,Ltd. (560451976)