Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID eb30e5de-9074-4760-8e92-e1d1c127227d

Route

TOPICAL

Published

Effective Date 2017-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Iodine (10 mg)

Inactive Ingredients

Glycerin Nonoxynol-10 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-01-01

Description

Active Ingredients Povidone Iodine 10%

Medication Information

Warnings and Precautions

Warnings

For external use only

Avoid use on persons allergic to iodine

Indications and Usage

Uses

prepping intact skin and mucous membranes prior to surgery

Dosage and Administration

Directions

Patient preoperative prep

apply solution to operative site following povidone iodine scrub application

using a circular motion, start at incision site and move outward

remove all soiled underdrapes

Do not allow solution to pool

Description

Active Ingredients Povidone Iodine 10%

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop using this product and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Section 51727-6

Inactive Ingredients

Glycerin, Nonoxynol - 10, Purified Water

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredients

Povidone Iodine 10%

Package Label

Other Information

store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free

Structured Label Content

Indications and Usage (34067-9)

Uses

prepping intact skin and mucous membranes prior to surgery

Dosage and Administration (34068-7)

Directions

Patient preoperative prep

apply solution to operative site following povidone iodine scrub application

using a circular motion, start at incision site and move outward

remove all soiled underdrapes

Do not allow solution to pool

Warnings and Precautions (34071-1)

Warnings

For external use only

Avoid use on persons allergic to iodine

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop using this product and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Section 51727-6 (51727-6)

Inactive Ingredients

Glycerin, Nonoxynol - 10, Purified Water

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredients

Povidone Iodine 10%

Package Label

Other Information (Other information)

store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free

Advanced Ingredient Data

[{"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": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses prepping intact skin and mucous membranes prior to surgery", "34068-7": "Directions Patient preoperative prep apply solution to operative site following povidone iodine scrub application using a circular motion, start at incision site and move outward remove all soiled underdrapes Do not allow solution to pool", "34071-1": "Warnings For external use only Avoid use on persons allergic to iodine", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact Poison Control Center right away", "50566-9": "Stop using this product and ask a doctor if Skin shows symptoms of irritation, sensitivity, redness, pain or swelling", "51727-6": "Inactive Ingredients Glycerin, Nonoxynol - 10, Purified Water", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredients Povidone Iodine 10%", "Other information": "store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:34.482396 · Updated: 2026-03-14T23:01:28.904310