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NDC 81280-0002-01 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	81280-0002
Product ID	81280-002_48e3b9e9-8c1d-4b47-9e30-681c2fab38ff
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 81280-0002-01 (81280000201)

Pricing Information	N/A
NDC Package Code	81280-002-01
Billing NDC	81280000201
Package	2000 POUCH in 1 CARTON (81280-002-01) / 1 APPLICATOR in 1 POUCH / .34 mL in 1 APPLICATOR
Marketing Start Date	2021-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3dc3303f-54b2-4aec-8568-5e0f8eb7cb14 Details

Active ingredient

Povidone-Iodine, USP, 10% v/v

(equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

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
apply product on the area 1-3 times daily
may be covered with a sterile bandage when dry

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 - 2000 Pouch Carton Label

Mazza Healthcare

MODEL NO.: 02-050-00

DESCRIPTION: POVIDONE-IODINE PREP PADS, MEDIUM

NON-STERILE

QUANTITY: 1 CASE (2000 EACH)

LOT NO.:

MANUFACTURE DATE:

EXPIRY DATE:

MANUFACTURED FOR:

Mazza Healthcare, LLC

Bannockburn, IL 60015 • USA

MADE IN CHINA

NDC 81280-002-01

Principal Display Panel - 2000 Pouch Carton Label

Principal Display Panel - 1 Prep Pad Pouch Label

Mazza Healthcare

Povidone-Iodine

Prep Pad

NDC 81280-002-01

Antiseptic • Germicide

Medium • 2-Ply

Non-Sterile • Single Use Only

Reorder No. 02-050-00

Principal Display Panel - 1 Prep Pad Pouch Label

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE

povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81280-002
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:81280-002-01	2000 in 1 CARTON	03/01/2021
1		1 in 1 POUCH
1		0.34 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: 48e3b9e9-8c1d-4b47-9e30-681c2fab38ff

Set id: 3dc3303f-54b2-4aec-8568-5e0f8eb7cb14

Version: 1

Effective Time: 20210204