HALODINE ORAL ANTISEPTIC- povidone-iodine spray 
Halodine Llc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Halodine Oral Antiseptic Spray

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%

(0.125% Available Iodine)

Purpose

Antiseptic

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.

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

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

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

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HALODINE ORAL ANTISEPTIC 
povidone-iodine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78371-401
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78371-401-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/01/2020
Labeler - Halodine Llc (117526113)

Revised: 10/2020
Document Id: 2ca898e7-199b-487d-802d-b662ab2a2db2
Set id: 0c834b76-f367-4550-9b4e-82ade5df7094
Version: 1
Effective Time: 20201014
 
Halodine Llc