Povidone Iodine Topical Solution Paint

SPL v4

SPL

SPL Set ID 42778607-6170-4a5e-94d0-5e6cd064eec6

Route

TOPICAL

Published

Effective Date 2019-12-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (100 mg)

Inactive Ingredients

Citric Acid Acetate Glycerin Nonoxynol-9 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-03-31

Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

prepping intact skin and mucous membranes prior to sugery

Section 42229-5

Drug Facts

Warnings

for external use only

avoid use on persons allergic to iodine

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 no allow solution to pool

Package Labeling

Active Ingredient

Povidone-Iodine, USP 10%

(1.0% available iodine)

Other Information

store at room temperature
avoid excessive heat (above 104 degrees F/40 degrees C)
protect from freezing
latex free

Inactive Ingredients

Citric acid, glycerol, nonylphenol ethoxylate, Purified Water, sodium hydroxide

Keep Out of Reach of Children.

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

Stop Using This Product and Ask A Doctor If

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

Structured Label Content

Use

prepping intact skin and mucous membranes prior to sugery

Section 42229-5 (42229-5)

Drug Facts

Purpose

Antiseptic

Warnings

for external use only

avoid use on persons allergic to iodine

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 no allow solution to pool

Package Labeling

Active Ingredient

Povidone-Iodine, USP 10%

(1.0% available iodine)

Other Information (Other information)

store at room temperature
avoid excessive heat (above 104 degrees F/40 degrees C)
protect from freezing
latex free

Inactive Ingredients

Citric acid, glycerol, nonylphenol ethoxylate, Purified Water, sodium hydroxide

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

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)

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

Advanced Ingredient Data

[{"name": "CITRIC ACID ACETATE", "unii": "DSO12WL7AU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-9", "unii": "48Q180SH9T", "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": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "prepping intact skin and mucous membranes prior to sugery", "42229-5": "Drug Facts", "Purpose": "Antiseptic", "Warnings": "for external use only avoid use on persons allergic to iodine", "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 no allow solution to pool", "Active Ingredient": "Povidone-Iodine, USP 10% (1.0% available iodine)", "Other information": "store at room temperature avoid excessive heat (above 104 degrees F/40 degrees C) protect from freezing latex free", "Inactive Ingredients": "Citric acid, glycerol, nonylphenol ethoxylate, Purified Water, sodium hydroxide", "Keep out of reach of children.": "if swallowed, get medical help or contact a Poison Control Center right away", "Stop using this product and ask a doctor if": "skin shows symptoms of irritation, sensitivity, redness, pain or swelling"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:34.430739 · Updated: 2026-03-14T23:01:27.375563