POVIDONE-IODINE- povidone-iodine swab 
Mazza Healthcare, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

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

Purpose

Antiseptic

Uses

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

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 - 500 Pouch Carton Label

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 - 3 Applicators Pouch Label

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 - 500 Pouch Carton Label

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

Principal Display Panel - 1 Applicator Pouch Label
POVIDONE-IODINE 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81280-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Nonoxynol-10 (UNII: K7O76887AP)  
Water (UNII: 059QF0KO0R)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81280-003-01500 in 1 CARTON03/01/2021
11 in 1 POUCH
12.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:81280-003-03500 in 1 CARTON03/01/2021
23 in 1 POUCH
24.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/01/2021
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
 
Mazza Healthcare, LLC