Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID e1789944-3a41-4c86-b173-3a6993ae2141

Route

TOPICAL

Published

Effective Date 2017-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Iodine (7.5 mg)

Inactive Ingredients

Citric Acid Monohydrate Nonoxynol-10 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-01-01

Description

Active Ingredients Povidone Iodine, USP 7.5% (0.75% available Iodine)

Medication Information

Warnings and Precautions

Warnings

For external use only

Avoid use on persons allergic to iodine

Indications and Usage

Uses

For preparation of skin and mucous membranes prior to surgery

Dosage and Administration

Directions

Patient preoperative prep

use full strength

apply solution saturated sponge to operative site

scrub in circular motion for 5 minutes starting at incision site and move outward

blot with sterile towel

follow with application of topical solution

Description

Active Ingredients Povidone Iodine, USP 7.5% (0.75% available Iodine)

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 use and ask a doctor if

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

Section 51727-6

Inactive Ingredients

alkyl polyglucoside, citric acid, nonoxynol - 10, purified water, sodium hydroxide

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredients

Povidone Iodine, USP 7.5% (0.75% available Iodine)

Package Label

Other Information

store at room temperature avoid excessive heat (above104oF/40oC) protect from freezing latex free

Structured Label Content

Indications and Usage (34067-9)

Uses

For preparation of skin and mucous membranes prior to surgery

Dosage and Administration (34068-7)

Directions

Patient preoperative prep

use full strength

apply solution saturated sponge to operative site

scrub in circular motion for 5 minutes starting at incision site and move outward

blot with sterile towel

follow with application of topical solution

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 use and ask a doctor if

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

Section 51727-6 (51727-6)

Inactive Ingredients

alkyl polyglucoside, citric acid, nonoxynol - 10, purified water, sodium hydroxide

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredients

Povidone Iodine, USP 7.5% (0.75% available Iodine)

Package Label (Package label)

Other Information (Other information)

store at room temperature avoid excessive heat (above104oF/40oC) protect from freezing latex free

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "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": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "7.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For preparation of skin and mucous membranes prior to surgery", "34068-7": "Directions Patient preoperative prep use full strength apply solution saturated sponge to operative site scrub in circular motion for 5 minutes starting at incision site and move outward blot with sterile towel follow with application of topical solution", "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 use and ask a doctor if Skin shows symptoms of irritation, sensitivity, redness, pain or swelling", "51727-6": "Inactive Ingredients alkyl polyglucoside, citric acid, nonoxynol - 10, purified water, sodium hydroxide", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredients Povidone Iodine, USP 7.5% (0.75% available Iodine)", "Other information": "store at room temperature avoid excessive heat (above104oF/40oC) protect from freezing latex free"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:34.477723 · Updated: 2026-03-14T23:01:28.904310