Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 31df570a-35ae-41a2-b04a-fce65e9d596d

Route

TOPICAL

Published

Effective Date 2024-11-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Iodine (0.1 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Nonoxynol-10 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

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

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

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

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

Section 50565-1

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

Section 50566-9

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

Section 50569-3

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

Warnings

For external use only

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.

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.

Active Ingredient

Povidone-Iodine, USP, 10% v/v

(equivalent to 1% titratable iodine)

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 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 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

Structured Label Content

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

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

Purpose

Antiseptic

Warnings

For external use only

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.

Do Not Use (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.

Active Ingredient (Active ingredient)

Povidone-Iodine, USP, 10% v/v

(equivalent to 1% titratable iodine)

Other Information (Other information)

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

Inactive Ingredients (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 (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 1 Applicator Pouch Label (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 3 Applicators Pouch 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

Advanced Ingredient Data

[{"name": "Iodine", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "0.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Citric Acid Monohydrate", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Nonoxynol-10", "unii": "K7O76887AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and consult a doctor if the condition persists or gets worse.", "50569-3": "Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.", "Purpose": "Antiseptic", "Warnings": "For external use only", "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.", "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.", "Active ingredient": "Povidone-Iodine, USP, 10% v/v (equivalent to 1% titratable iodine)", "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 - 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 - 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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:31.449965 · Updated: 2026-03-14T23:05:20.270582