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Halodine Oral Rinse

Dosage form: solution
Ingredients: POVIDONE-IODINE 1.75mg in 1mL
Labeler: Halodine LLC
NDC code: 78371-201

Medically reviewed by Drugs.com. Last updated on Jun 28, 2024.

Halodine Oral Rinse

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.75%

(0.175% 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

When using this product:

Do not swallow

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 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. Twist off the narrow end of single ampoule.
  2. Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.
  3. Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.
  4. Slightly lift chin and tilt head back to gargle, then spit out.

Children under 3 years of age: Consult a dentist or doctor

Other Information
  • Single use only; do not reuse
  • Not made with natural rubber latex
  • Store at room temperature; avoid excessive heat

Inactive Ingredients

hydroxyethylcellulose, purified water

Questions or comments?

contact@halodine.com

Principal Display Panel

HALODINE ORAL RINSE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78371-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE1.75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDROXYETHYL CELLULOSE, UNSPECIFIED 
Packaging
#Item CodePackage Description
1NDC:78371-201-01100 AMPULE in 1 CARTON
13.2 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/15/2020
Labeler - Halodine LLC (117526113)

Revised: 07/2020
Document Id: a9ee4c33-4a5c-3a1f-e053-2995a90aa515
Set id: a9ee4c33-4a5b-3a1f-e053-2995a90aa515
Version: 1
Effective Time: 20200708
 
Halodine LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer