HALODINE ORAL ANTISEPTIC- povidone-iodine spray

Halodine Oral Antiseptic by

Drug Labeling and Warnings

Halodine Oral 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

INDICATIONS & USAGE

Uses  Oral Antiseptic  First aid to help prevent infection in minor oral irritation caused by dental procedures

Warnings For external use only.

Do not use  If allergic to iodine  In the eyes  On children less than 3 years old  For more than 7 days unless directed by a dentist or doctor Stop use and promptly ask your dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

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

DOSAGE & ADMINISTRATION

Directions For oral antisepsis in adults and children 3 years of age and older:
1. Press down pump completely and spray twice into mouth. 2. Swish vigorously in mouth for 15 seconds. 3. Slightly lift chin and tilt head back to gargle. Spit out excess. Children under 3 years of age: Consult a dentist or doctor

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Inactive Ingredients hydroxyethylcellulose, purified water

QUESTIONS

Questions or comments? contact@halodine.com

SPL UNCLASSIFIED SECTION

Povidone-Iodine USP, 1.25%

Helps Reduce Risk of Infection

4-Hour Formula

halodine.com

PATENT PENDING

Manufactured in the U.S.A.

for Halodine LLC 111 NE 1st St,

Ste 806, Miami, FL 33132

Packaging

INGREDIENTS AND APPEARANCE

HALODINE ORAL ANTISEPTIC 
povidone-iodine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78371-401
Route of Administration	ORAL

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: 78371-401-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/01/2020

Labeler - Halodine Llc (117526113)