OP FIRST AID SERIES POVIDONE IODINE PREP PAD- povidone-iodine cloth

OP First Aid Series Povidone Iodine Prep Pad by

Drug Labeling and Warnings

OP First Aid Series Povidone Iodine Prep Pad 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 (equivalent to iodine 1%)

Purpose

Antiseptic

Use

• Antiseptic for preparation of the skin.
• First aid antiseptic to help prevent skin infection.

Warnings

For external use only.

Do not use 

Avoid contact with eyes.If happens,rinse thoroughly with water.

Stop use 

In case of deep or puncture wounds or serious burns,and if pain,irritation, redness, swelling,or infection occurs,discontinue use and contact a physician.

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away.

Directions

Clean intended area thoroughly with pad.discard after single use.

Other information

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

Inactive ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

OP FIRST AID SERIES POVIDONE IODINE PREP PAD 
povidone-iodine cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72459-012
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 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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: 72459-012-01	1 in 1 POUCH	11/03/2020
1		0.55 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	11/03/2020

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