Halodine Oral Rinse
a9ee4c33-4a5b-3a1f-e053-2995a90aa515
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Povidone-Iodine USP, 1.75% (0.175% Available Iodine)
Purpose
Antiseptic
Medication Information
Purpose
Antiseptic
Description
Povidone-Iodine USP, 1.75% (0.175% Available Iodine)
Uses
- Oral Antiseptic
- First aid to help prevent infection in minor oral irritation caused by dental procedures
Section 42229-5
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
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
Packaging
Directions
For oral antisepsis in adults and children 3 years of age and older:
- Twist off the narrow end of single ampoule.
- Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.
- Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.
- Slightly lift chin and tilt head back to gargle, then spit out.
Children under 3 years of age: Consult a dentist or doctor
Drug Facts
Active Ingredient
Povidone-Iodine USP, 1.75%
(0.175% Available Iodine)
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?
Structured Label Content
Uses
- Oral Antiseptic
- First aid to help prevent infection in minor oral irritation caused by dental procedures
Section 42229-5 (42229-5)
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
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose
Antiseptic
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.
Packaging
Directions
For oral antisepsis in adults and children 3 years of age and older:
- Twist off the narrow end of single ampoule.
- Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.
- Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.
- Slightly lift chin and tilt head back to gargle, then spit out.
Children under 3 years of age: Consult a dentist or doctor
Drug Facts
Active Ingredient
Povidone-Iodine USP, 1.75%
(0.175% Available Iodine)
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? (Questions or comments?)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:59:03.242902 · Updated: 2026-03-14T22:58:52.562418