Povidone Iodine Topical Solution Usp

Povidone Iodine Topical Solution Usp
SPL v1
SPL
SPL Set ID 37c709ae-ef37-0b46-e063-6394a90af861
Route
TOPICAL
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Anhydrous Nonoxynol-9 Sodium Hydroxide Water

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

Description

10% Povidone Iodine Solution USP, (1% available Iodine)

Purpose

Topical Antiseptic


Medication Information

Purpose

Topical Antiseptic

Description

10% Povidone Iodine Solution USP, (1% available Iodine)

Uses

First Aid Antiseptic To Help prevent infection in minor skin cuts and abrasions and burns.

Section 50565-1

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

Section 51945-4

carton label

Warnings

For external use only.

Do not use in the eyes; if you are allergic to any of the ingredients; longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have• deep or puncture wounds • serious burns

Stop use and ask a doctor if • redness, irritation, swelling or pain persists or increases

• infection occurs.

Directions

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury. Discard after single use.

Questions?

Call 1-800.835.2263

Other Information

Store at room temperature away from light. Keep from freezing or excessive heat.

Inactive Ingredients

Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

Active Ingredients (each Swab)

10% Povidone Iodine Solution USP, (1% available Iodine)


Structured Label Content

Uses

First Aid Antiseptic To Help prevent infection in minor skin cuts and abrasions and burns.

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

carton label

Purpose

Topical Antiseptic

Warnings

For external use only.

Do not use in the eyes; if you are allergic to any of the ingredients; longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have• deep or puncture wounds • serious burns

Stop use and ask a doctor if • redness, irritation, swelling or pain persists or increases

• infection occurs.

Directions

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury. Discard after single use.

Questions?

Call 1-800.835.2263

Other Information

Store at room temperature away from light. Keep from freezing or excessive heat.

Inactive Ingredients

Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

Active Ingredients (each Swab) (Active Ingredients (each swab))

10% Povidone Iodine Solution USP, (1% available Iodine)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)