halodine®

halodine®
SPL v1
SPL
SPL Set ID 275f078b-6c70-43d1-bafe-b0156f9ed73e
Route
topical
Published
Effective Date 2021-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (1.25 g)
Inactive Ingredients
hydroxyethyl cellulose, unspecified water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-02-01

Purpose

Antiseptic

Description

Povidone-Iodine USP, 1.25% (0.125% Available Iodine)


Medication Information

Warnings

For external use only.

Do not use • If allergic to iodine • In the eyes 

• On children less than 3 years old

• Over large areas of the body

Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

Uses

• Kills germs • Helps reduce bacteria that cause infections

Purpose

Antiseptic

Directions

For nasal application to skin inside of nostrils in adults and children 3 years of age and older:

1. Gently blow nose to clear both nostrils. Discard tissue.

2. Remove cap.

3. Close one nostril and put only the tip of spray nozzle in other nostril. Aim slightly away from center of nose.

4. While sniffing gently, press down the spray nozzle twice. You'll feel a light mist in your nose. Breathe out through your mouth. 

5. Repeat in other nostril. Wipe spray nozzle with clean tissue and replace cap.

Children under 3 years of age: Consult a doctor.

Other Information

• Not made with natural rubber latex • Store at room temperature; avoid excessive heat 

Inactive Ingredients

hydroxyethylcellulose, purified water

Description

Povidone-Iodine USP, 1.25% (0.125% Available Iodine)

Section 42229-5

STOP VIRUSES BEFORE THEY SPREAD 

Kills viruses and bacteria that cause infections 

Kills the virus that causes COVID-19

4 Hour Formula

Inactivates the SARS-CoV-2 virus in less than 15 seconds

Distributed by

Halodine LLC

111 NE 1st St

Suite 806

Miami, FL 33132

Made in the U.S.A

halodine.com

Section 50565-1

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

Packaging

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%

(0.125% Available Iodine)

Questions Or Comments?

Structured Label Content

Warnings

For external use only.

Do not use • If allergic to iodine • In the eyes 

• On children less than 3 years old

• Over large areas of the body

Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

Uses

• Kills germs • Helps reduce bacteria that cause infections

Purpose

Antiseptic

Directions

For nasal application to skin inside of nostrils in adults and children 3 years of age and older:

1. Gently blow nose to clear both nostrils. Discard tissue.

2. Remove cap.

3. Close one nostril and put only the tip of spray nozzle in other nostril. Aim slightly away from center of nose.

4. While sniffing gently, press down the spray nozzle twice. You'll feel a light mist in your nose. Breathe out through your mouth. 

5. Repeat in other nostril. Wipe spray nozzle with clean tissue and replace cap.

Children under 3 years of age: Consult a doctor.

Other Information

• Not made with natural rubber latex • Store at room temperature; avoid excessive heat 

Inactive Ingredients

hydroxyethylcellulose, purified water

Section 42229-5 (42229-5)

STOP VIRUSES BEFORE THEY SPREAD 

Kills viruses and bacteria that cause infections 

Kills the virus that causes COVID-19

4 Hour Formula

Inactivates the SARS-CoV-2 virus in less than 15 seconds

Distributed by

Halodine LLC

111 NE 1st St

Suite 806

Miami, FL 33132

Made in the U.S.A

halodine.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.

Packaging

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%

(0.125% Available Iodine)

Questions Or Comments? (Questions or comments?)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)