Drug Facts

Drug Facts

SPL v9

SPL

SPL Set ID f1b4f6fd-2806-4273-8c72-e7c3d5bca4ac

Route

TOPICAL

Published

Effective Date 2011-08-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Iodine (0.10 mL)

Inactive Ingredients

Citric Acid Glycerin Water Sodium Hydroxide Sodium Phosphate, Dibasic, Dihydrate Nonoxynol-9 Polysorbate 80 Sodium Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2007-01-01 Until 2014-08-31

Description

Povidone Iodine 10% (equivalent to 1% available iodine)

Purpose

First Aid Antiseptic

Medication Information

Purpose

First Aid Antiseptic

Description

Povidone Iodine 10% (equivalent to 1% available iodine)

Uses

Healthcare antiseptic for preparation of the skin prior to surgery
First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Questions

1-800-MEDLINE

Directions

Clean the affected area.

For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Do Not Use

in the eyes
longer than 1 week unless directed by a doctor
on individuals who are allergic or sensitive to iodine
or apply over large areas of the body

Active Ingredient

Povidone Iodine 10% (equivalent to 1% available iodine)

Other Information

Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.

Stop Use and Ask A Doctor

if irritation and redness develop
if condition persists for more than 72 hours
in case of deep or puncture wounds, animal bites or serious burns

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Drug Facts Panel Prep Pad Bulk Case

Drug Facts Panel Prep Pads, Medium Box

Drug Facts Panel Swabstick Singles Box

Drug Facts Panel Swabstick Triples Box

Principal Display Panel Prep Pad Bulk Case

Povidone Iodine

Prep PADS

Medium Bulk

MDS093918

Contents: 3,000 Each Per Case

Principal Display Panel Prep Solution Label

N: 53329-900-55

Medline

Prep Solution

with

Spray Bottle

Topical Antiseptic

Microbicide

MDS093942

latex free

Do not reuse

2 FL OZ (59 mL)

Principal Display Panel Prep Solution Bottle

NDC: 53329-939-13

MEDLINE

PVP Prep Solution

Topical Antiseptic

Povidone-Iodine 10%

MDS093940

latexfree

www.medline.com

Manufactured for: Medline Industries, Inc.

Mundelein, IL 60060 USA Made in USA

To Order Call: 1-800-MEDLINE

RB11CTR

2 FL OZ (59 mL)

Principal Display Panel Prep Pads, Medium Box

Medline

Antiseptic

Povidone Iodine Prep Pads, Medium

MDS093917

For hospital and professional use.

Contents: 100 Pads

Principal Display Panel Swabstick Singles Box

NDC: 53329-945-29

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Singles

MDS093901

Discard appropriately after single use.

Protect from Freezing. Avoid excessive heat. For external use only.

latex free

Contents: 50 Each

Principal Display Panel Swabstick Triples Box

NDC 53329-946-75

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Triples

MDS093902

Discard appropriately after single use.

Protect from freezing. Avoid excessive heat. For external use only.

latex free

Contents: 25 Pouches

Principal Display Panel Swabstick Singles Pouch

NDC53329-945-09

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Singles

MDS093901

latex free

For professional and hospital use.

Contents: 1 Swabstick

Structured Label Content

Uses

Healthcare antiseptic for preparation of the skin prior to surgery
First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Purpose

First Aid Antiseptic

Warnings

For external use only.

Questions

1-800-MEDLINE

Directions

Clean the affected area.

For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Do Not Use (Do not use)

in the eyes
longer than 1 week unless directed by a doctor
on individuals who are allergic or sensitive to iodine
or apply over large areas of the body

Active Ingredient (Active ingredient)

Povidone Iodine 10% (equivalent to 1% available iodine)

Other Information (Other information)

Protect from freezing. Avoid excessive heat.

Inactive Ingredients (Inactive ingredients)

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation and redness develop
if condition persists for more than 72 hours
in case of deep or puncture wounds, animal bites or serious burns

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Drug Facts Panel Prep Pad Bulk Case (Drug Facts Panel - Prep Pad Bulk case)

Drug Facts Panel Prep Pads, Medium Box (Drug Facts Panel - Prep Pads, Medium box)

Drug Facts Panel Swabstick Singles Box (Drug Facts Panel - Swabstick Singles box)

Drug Facts Panel Swabstick Triples Box (Drug Facts Panel - Swabstick Triples box)

Principal Display Panel Prep Pad Bulk Case (Principal Display Panel - Prep Pad Bulk case)

Povidone Iodine

Prep PADS

Medium Bulk

MDS093918

Contents: 3,000 Each Per Case

Principal Display Panel Prep Solution Label (Principal Display Panel - Prep Solution label)

N: 53329-900-55

Medline

Prep Solution

with

Spray Bottle

Topical Antiseptic

Microbicide

MDS093942

latex free

Do not reuse

2 FL OZ (59 mL)

Principal Display Panel Prep Solution Bottle (Principal Display Panel - Prep Solution bottle)

NDC: 53329-939-13

MEDLINE

PVP Prep Solution

Topical Antiseptic

Povidone-Iodine 10%

MDS093940

latexfree

www.medline.com

Manufactured for: Medline Industries, Inc.

Mundelein, IL 60060 USA Made in USA

To Order Call: 1-800-MEDLINE

RB11CTR

2 FL OZ (59 mL)

Principal Display Panel Prep Pads, Medium Box (Principal Display Panel - Prep Pads, Medium box)

Medline

Antiseptic

Povidone Iodine Prep Pads, Medium

MDS093917

For hospital and professional use.

Contents: 100 Pads

Principal Display Panel Swabstick Singles Box (Principal Display Panel - Swabstick Singles box)

NDC: 53329-945-29

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Singles

MDS093901

Discard appropriately after single use.

Protect from Freezing. Avoid excessive heat. For external use only.

latex free

Contents: 50 Each

Principal Display Panel Swabstick Triples Box (Principal Display Panel - Swabstick Triples box)

NDC 53329-946-75

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Triples

MDS093902

Discard appropriately after single use.

Protect from freezing. Avoid excessive heat. For external use only.

latex free

Contents: 25 Pouches

Principal Display Panel Swabstick Singles Pouch (Principal Display Panel - Swabstick Singles pouch)

NDC53329-945-09

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Singles

MDS093901

latex free

For professional and hospital use.

Contents: 1 Swabstick

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Iodine", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "0.10", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "1"}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "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": ""}, {"name": "Iodine", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "0.10", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "1"}, {"name": "Citric Acid", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "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": ""}, {"name": "Iodine", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "0.10", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "1"}, {"name": "Citric Acid", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "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": ""}, {"name": "Iodine", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Citric Acid", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, DIHYDRATE", "unii": "94255I6E2T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-9", "unii": "48Q180SH9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Iodine", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polysorbate 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Citric Acid", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Citrate", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Iodine", "unii": "9679TC07X4", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polysorbate 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Citric Acid", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Citrate", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Healthcare antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent infection in minor cuts, scrapes and burns", "Purpose": "First Aid Antiseptic", "Warnings": "For external use only.", "Questions": "1-800-MEDLINE", "Directions": "Clean the affected area. For preparation of the skin prior to surgery: apply product to the operative site prior to surgery For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.", "Do not use": "in the eyes longer than 1 week unless directed by a doctor on individuals who are allergic or sensitive to iodine or apply over large areas of the body", "Active ingredient": "Povidone Iodine 10% (equivalent to 1% available iodine)", "Other information": "Protect from freezing. Avoid excessive heat.", "Inactive ingredients": "Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.", "Stop use and ask a doctor": "if irritation and redness develop if condition persists for more than 72 hours in case of deep or puncture wounds, animal bites or serious burns", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Principal Display Panel - Prep Pad Bulk case": "Povidone Iodine Prep PADS Medium Bulk MDS093918 Contents: 3,000 Each Per Case", "Principal Display Panel - Prep Solution label": "N: 53329-900-55 Medline Prep Solution with Spray Bottle Topical Antiseptic Microbicide MDS093942 latex free Do not reuse 2 FL OZ (59 mL)", "Principal Display Panel - Prep Solution bottle": "NDC: 53329-939-13 MEDLINE PVP Prep Solution Topical Antiseptic Povidone-Iodine 10% MDS093940 latexfree www.medline.com Manufactured for: Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA To Order Call: 1-800-MEDLINE RB11CTR 2 FL OZ (59 mL)", "Principal Display Panel - Prep Pads, Medium box": "Medline Antiseptic Povidone Iodine Prep Pads, Medium MDS093917 For hospital and professional use. Contents: 100 Pads", "Principal Display Panel - Swabstick Singles box": "NDC: 53329-945-29 Medline Antiseptic Povidone-Iodine, USP Swabsticks, Singles MDS093901 Discard appropriately after single use. Protect from Freezing. Avoid excessive heat. For external use only. latex free Contents: 50 Each", "Principal Display Panel - Swabstick Triples box": "NDC 53329-946-75 Medline Antiseptic Povidone-Iodine, USP Swabsticks, Triples MDS093902 Discard appropriately after single use. Protect from freezing. Avoid excessive heat. For external use only. latex free Contents: 25 Pouches", "Principal Display Panel - Swabstick Singles pouch": "NDC53329-945-09 Medline Antiseptic Povidone-Iodine, USP Swabsticks, Singles MDS093901 latex free For professional and hospital use. Contents: 1 Swabstick"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:19.540533 · Updated: 2026-03-14T22:52:49.153069