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NDC 81280-0003-03 Povidone-Iodine 0.1 mg/mL Details

Povidone-Iodine 0.1 mg/mL

Povidone-Iodine is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Mazza Healthcare, LLC. The primary component is POVIDONE-IODINE.

Product Information

NDC	81280-0003
Product ID	81280-003_63b1becd-3420-4873-b768-01c79a2f1ae6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Povidone-Iodine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Povidone-Iodine
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	0.1
Active Ingredient Units	mg/mL
Substance Name	POVIDONE-IODINE
Labeler Name	Mazza Healthcare, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2024-12-31

Package

Package Images

NDC 81280-0003-03 (81280000303)

Pricing Information	N/A
NDC Package Code	81280-003-03
Billing NDC	81280000303
Package	500 POUCH in 1 CARTON (81280-003-03) / 3 APPLICATOR in 1 POUCH / 4.5 mL in 1 APPLICATOR
Marketing Start Date	2021-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 31df570a-35ae-41a2-b04a-fce65e9d596d Details

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
apply product on 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

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 - 500 Pouch Carton Label

Principal Display Panel - 3 Applicators Pouch Label

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 - 3 Applicators Pouch Label

Principal Display Panel - 500 Pouch Carton Label

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

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

Principal Display Panel - 1 Applicator Pouch Label

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	03/01/2021

Labeler - Mazza Healthcare, LLC (830069063)

Revised: 2/2021

Document Id: 63b1becd-3420-4873-b768-01c79a2f1ae6

Set id: 31df570a-35ae-41a2-b04a-fce65e9d596d

Version: 1

Effective Time: 20210204

Search by Drug Name or NDC

NDC 81280-0003-03 Povidone-Iodine 0.1 mg/mL Details

Povidone-Iodine 0.1 mg/mL

Product Information

Package

Package Images

NDC 81280-0003-03 (81280000303)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 31df570a-35ae-41a2-b04a-fce65e9d596d Details

Active ingredient

Purpose

Uses

Warnings

Do not use

Directions

Other information

Inactive ingredients

Principal Display Panel - 500 Pouch Carton Label

Principal Display Panel - 3 Applicators Pouch Label

Principal Display Panel - 500 Pouch Carton Label

Principal Display Panel - 1 Applicator Pouch Label

INGREDIENTS AND APPEARANCE

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