1413, 1414, 1415, 1416

SPL v6

SPL

SPL Set ID 6bb4d55b-2be7-3549-e053-2a91aa0a2bb0

Route

topical

Published

Effective Date 2018-05-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

iodine (10 mg)

Inactive Ingredients

glycerin citric acid monohydrate water polysorbate 80 sodium phosphate sodium citrate

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2018-05-08

Purpose

Healthcare Antiseptic

Description

Povidone-iodine 10%

Medication Information

Warnings

For external use only

Purpose

Healthcare Antiseptic

Directions

Clean the area. Apply product to the operative site prior to surgery.

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80

Description

Povidone-iodine 10%

Questions?

1-888-DYNAREX

Use

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Other

Store at controlled room temperature.

Section 50565-1

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

Labeling

Do Not Use

if allergic to iodine
in the eyes

Active Ingredient

Povidone-iodine 10%

Stop Use and Ask A Doctor If

irritation and redness develop
condition persists for more than 72 hours

Structured Label Content

Warnings

For external use only

Purpose

Healthcare Antiseptic

Directions

Clean the area. Apply product to the operative site prior to surgery.

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80

Questions?

1-888-DYNAREX

Use

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Other

Store at controlled room temperature.

Section 50565-1 (50565-1)

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

Labeling

Do Not Use

if allergic to iodine
in the eyes

Active Ingredient

Povidone-iodine 10%

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

irritation and redness develop
condition persists for more than 72 hours

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE", "unii": "SE337SVY37", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "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)

{"Use": "For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection", "Other": "Store at controlled room temperature.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Healthcare Antiseptic", "Warnings": "For external use only", "Directions": "Clean the area. Apply product to the operative site prior to surgery.", "Do Not Use": "if allergic to iodine in the eyes", "Questions?": "1-888-DYNAREX", "Active Ingredient": "Povidone-iodine 10%", "Inactive Ingredients": "Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80", "Stop use and ask a doctor if": "irritation and redness develop condition persists for more than 72 hours"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:29.258199 · Updated: 2026-03-14T23:05:15.511736