Drug Fact

Drug Fact
SPL v2
SPL
SPL Set ID 8d8a21d3-7d8b-4174-8c21-736cf3d3d869
Route
PERCUTANEOUS
Published
Effective Date 2014-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (0.01 mg)
Inactive Ingredients
Water Citric Acid Monohydrate Sodium Phosphate, Dibasic Sodium Hydroxide Nonoxynol-9

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-05-20
Description

POVIDONE-IODINE USP 10% 

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

POVIDONE-IODINE USP 10% 

Use

Antiseptic skin preparation

Section 51945-4

Warnings

Do not use if allergic to iodine.

For External use only.

Ask a doctor before use if injuries are 

--Deep or puncture wounds

--serious bums 

stop use ask a doctor if 

--reness ,irritation ,swelling or pain persists or increases

--infection occurs

Do not use in eyes

Avoid "pooling "benesth patient.Prolonged exposure to wet solution may cause skin irrtation.

Directions

Apple locally as needed.

Active Ingredient

POVIDONE-IODINE USP 10% 

Other Information

--1% titrarabil iodine --latex free ---for hospital or professional use only

Inactive Ingredients

citric acid,disodium,phosphate,nonoxynol-9,sodium hydrexide,Water

Keep Out of Reach of Children.

Keep out of reach of children.in case of axxidental ingestion,seek professional assistance or consult a poison control center immediately.

Structured Label Content

Use

Antiseptic skin preparation

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

Do not use if allergic to iodine.

For External use only.

Ask a doctor before use if injuries are 

--Deep or puncture wounds

--serious bums 

stop use ask a doctor if 

--reness ,irritation ,swelling or pain persists or increases

--infection occurs

Do not use in eyes

Avoid "pooling "benesth patient.Prolonged exposure to wet solution may cause skin irrtation.

Directions

Apple locally as needed.

Active Ingredient

POVIDONE-IODINE USP 10% 

Other Information (Other information)

--1% titrarabil iodine --latex free ---for hospital or professional use only

Inactive Ingredients

citric acid,disodium,phosphate,nonoxynol-9,sodium hydrexide,Water

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

Keep out of reach of children.in case of axxidental ingestion,seek professional assistance or consult a poison control center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:47.873215 · Updated: 2026-03-14T22:53:45.227062