HALODINE NASAL ANTISEPTIC- povidone-iodine spray

Halodine Nasal Antiseptic by

Drug Labeling and Warnings

Halodine Nasal Antiseptic by is a Otc medication manufactured, distributed, or labeled by Halodine Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%

(0.125% Available Iodine)

Purpose

Antiseptic

Uses

Kills germs  Helps reduce bacteria that cause infections

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.

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

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

Questions or comments?

contact@halodine.com

SPL UNCLASSIFIED SECTION

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

Packaging

INGREDIENTS AND APPEARANCE

HALODINE NASAL ANTISEPTIC 
povidone-iodine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78371-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78371-501-01	1 in 1 BOX	02/01/2021
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2021

Labeler - Halodine Llc (117526113)