Povidone-Iodine by Mazza Healthcare, LLC POVIDONE-IODINE swab

Povidone-Iodine by

Drug Labeling and Warnings

Povidone-Iodine by is a Otc medication manufactured, distributed, or labeled by Mazza Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Antiseptic

Uses

• health care antiseptic for preparation of the skin prior to surgery
• first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not use

• in the eyes
• on individuals who are allergic or sensitive to iodine
• over large areas of the body
• as first aid antiseptic longer than 1 week unless directed by doctor

Discontinue use if irritation and redness develop.

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

Stop use and consult a doctor if the condition persists or gets worse.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the affected area
• for preparation of the skin prior to surgery, apply product to the operative site
• for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other information

Store at room temperature 59-86ºF (15-30ºC).

Inactive ingredients

citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

Mazza Healthcare, LLC
1-877-629-9242

Principal Display Panel - 500 Pouch Carton Label

MH

Mazza Healthcare

MODEL NO.: 02-053-00

DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE

QUANTITY: 1 CASE (500 POUCHES X 3 EACH)

LOT NO.:

MANUFACTURE DATE:

EXPIRY DATE:

MANUFACTURED FOR:

Mazza Healthcare, LLC

Bannockburn, IL 60015 USA

MADE IN CHINA

NDC: 81280-003-03

Principal Display Panel - 3 Applicators Pouch Label

MH

Mazza Healthcare

Povidone-Iodine Swabsticks

NDC: 81280-003-03

Antiseptic Germicide 4” Saturated

Non-Sterile Single Use Only

3/pouch

Reorder Number 02-053-00

Principal Display Panel - 500 Pouch Carton Label

MH

Mazza Healthcare

MODEL NO.: 02-051-00

DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE

QUANTITY: 1 CASE (500 POUCHES X 1 EACH)

LOT NO.:

MANUFACTURE DATE:

EXPIRY DATE:

MANUFACTURED FOR:

Mazza Healthcare, LLC

Bannockburn, IL 60015 USA

MADE IN CHINA

NDC: 81280-003-01

Principal Display Panel - 1 Applicator Pouch Label

MH

Mazza Healthcare

Povidone-Iodine Swabstick

NDC: 81280-003-01

Antiseptic Germicide 4” Saturated

Non-Sterile Single Use Only

1/pouch

Reorder Number 02-051-00

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81280-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Iodine	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Nonoxynol-10 (UNII: K7O76887AP)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81280-003-01	500 in 1 CARTON	03/01/2021
1		1 in 1 POUCH
1		2.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 81280-003-03	500 in 1 CARTON	03/01/2021
2		3 in 1 POUCH
2		4.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/01/2021

Labeler - Mazza Healthcare, LLC (830069063)