Proheal Povidone Iodine Swabstick

Proheal Povidone Iodine Swabstick
SPL v2
SPL
SPL Set ID 974e1205-01ab-4599-9229-cdf5225d268a
Route
TOPICAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1 g)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Anhydrous Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-27

Description

Povidone-iodine USP, 10% w/v (equivalent to 1% titratable Iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-iodine USP, 10% w/v (equivalent to 1% titratable Iodine)

Uses:

• Health-care antiseptic for preparation of the skin prior to surgery

• First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns

Section 42229-5

FIRST AID ANTISEPTIC

HSA/FSA Eligible

Convenient Swab Format

INDIVIDUALLY WRAPPED

SINGLE USE ONLY

How to use:

Tear Open Packet

Use tear notch for easy opening.

Remove Swab

Hold away from surfaces.

Apply to Area

Wipe skin thoroughly. Allow to air dry.

Manufactured for: ProHeal

Surfside, FL

www.prohealproducts.com

Section 50565-1

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

Packaging

Warnings:

For external use only. Do not use or apply in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic longer than 1 week unless directed by a doctor

Discontinue use if irritation and redness develop.

Consult a doctor in case of deep or puncture wounds • animal bites • serious burns

Stop use and consult a doctor if the condition persists or gets worse.

Drug Facts

Directions:

For preparation of the skin prior to surgery clean the affected area, remove swab by stick, apply to the operative site prior to surgery.

For use as a first aid antiseptic clean the affected area, apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Active Ingredient

Povidone-iodine USP, 10% w/v

(equivalent to 1% titratable Iodine)

Other Information:

Store at room temperature.

Inactive Ingredients:

Citric acid, Disodium phosphate, Purified water.


Structured Label Content

Uses:

• Health-care antiseptic for preparation of the skin prior to surgery

• First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns

Section 42229-5 (42229-5)

FIRST AID ANTISEPTIC

HSA/FSA Eligible

Convenient Swab Format

INDIVIDUALLY WRAPPED

SINGLE USE ONLY

How to use:

Tear Open Packet

Use tear notch for easy opening.

Remove Swab

Hold away from surfaces.

Apply to Area

Wipe skin thoroughly. Allow to air dry.

Manufactured for: ProHeal

Surfside, FL

www.prohealproducts.com

Section 50565-1 (50565-1)

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

Purpose

Antiseptic

Packaging

Warnings:

For external use only. Do not use or apply in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic longer than 1 week unless directed by a doctor

Discontinue use if irritation and redness develop.

Consult a doctor in case of deep or puncture wounds • animal bites • serious burns

Stop use and consult a doctor if the condition persists or gets worse.

Drug Facts

Directions:

For preparation of the skin prior to surgery clean the affected area, remove swab by stick, apply to the operative site prior to surgery.

For use as a first aid antiseptic clean the affected area, apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Active Ingredient

Povidone-iodine USP, 10% w/v

(equivalent to 1% titratable Iodine)

Other Information: (Other information:)

Store at room temperature.

Inactive Ingredients: (Inactive ingredients:)

Citric acid, Disodium phosphate, Purified water.


Advanced Ingredient Data


Raw Label Data

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