POVIDONE IODINE PREP PAD STERILE- povidone-iodine cloth

POVIDONE IODINE PREP PAD Sterile by

Drug Labeling and Warnings

POVIDONE IODINE PREP PAD Sterile by is a Otc medication manufactured, distributed, or labeled by Jianerkang Medical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone Iodine USP, 10% w/w (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

For external use only.

Do not

• use in the eyes
• apply over large over large areas of the body
• use on individuals who are allergic or sensitive to iodine. 

Stop use and consult a doctor

• if the condition persists or gets worse
• for use longer than 1 week.

Ask a doctor 

in case of deep or puncture wounds, animal bites, serious burns.

keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the affected area
• Apply the product on the area and discard
• May be covered with a sterile bandage when dry.

Other information

• Avoid excessive heat.
• Store at room temperature.

Inactive ingredients

Citric acid, alkyl glucoside, hydroxyethyl cellulose, nonoxynol-10, glycerin, sodium hydroxide, potassium iodide, purified water

Package Labeling:0.4ml

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP PAD STERILE 
povidone-iodine cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-0022
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: 34645-0022-0	1 in 1 POUCH	11/19/2022
1		0.4 mL in 1 PATCH; 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	11/19/2022

Labeler - Jianerkang Medical Co., Ltd (530968767)