HALODINE ORAL RINSE- povidone-iodine solution

Halodine Oral Rinse by

Drug Labeling and Warnings

Halodine Oral Rinse 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, 1.75%

(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

SPL UNCLASSIFIED SECTION

Helps Reduce Risk of Infection

4-Hour Formula

Non-Sterile Antiseptic Solution

PATENT PENDING

Manufactured in the U.S.A. for Halodine LLC

111 NE 1st St, Ste 806, Miami, FL 33132

halodine.com

Packaging

INGREDIENTS AND APPEARANCE

HALODINE ORAL RINSE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78371-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1.75 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78371-201-03	10 in 1 CARTON	10/28/2020
1		3.2 mL in 1 AMPULE; Type 0: Not a Combination Product
2	NDC: 78371-201-01	100 in 1 CARTON	05/15/2020
2		3.2 mL in 1 AMPULE; Type 0: Not a Combination Product
3	NDC: 78371-201-02	200 in 1 CARTON	09/25/2020
3		3.8 mL in 1 AMPULE; 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	part356	05/15/2020

Labeler - Halodine LLC (117526113)