Indications and uses
Oral Antiseptic First aid to help prevent infection in minor oral irritation caused by dental procedures
Oral Antiseptic First aid to help prevent infection in minor oral irritation caused by dental procedures
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
Single use only; do not reuse Not made with natural rubber latex Store at room temperature; avoid excessive heat
Povidone-Iodine USP, 1.75%
(0.175% Available Iodine)
Antiseptic
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.
For oral antisepsis in adults and children 3 years of age and older:
Children under 3 years of age: Consult a dentist or doctor
hydroxyethylcellulose, purified water
contact@halodine.com
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
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78371-201-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7ee8-a426-e053-dadaa90af4c2 | Halodine Oral Rinse |
| 78371-201-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7ee8-a426-e053-dadaa90af4c2 | Halodine Oral Rinse |
| 78371-201-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7ee8-a426-e053-dadaa90af4c2 | Halodine Oral Rinse |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78371-201-01 | Halodine Oral Rinse | 3.2 mL in 1 AMPULE | SOLUTION | 3.2 | 3 | |
| 78371-201-01 | Halodine Oral Rinse | 100 in 1 CARTON | SOLUTION | 100 | 3 | |
| 78371-201-02 | Halodine Oral Rinse | 3.8 mL in 1 AMPULE | SOLUTION | 3.8 | 3 | |
| 78371-201-02 | Halodine Oral Rinse | 200 in 1 CARTON | SOLUTION | 200 | 3 | |
| 78371-201-03 | Halodine Oral Rinse | 10 in 1 CARTON | SOLUTION | 10 | 3 | |
| 78371-201-03 | Halodine Oral Rinse | 3.2 mL in 1 AMPULE | SOLUTION | 3.2 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 78371-201 | 78371-201-03, 78371-201-01, 78371-201-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| POVIDONE-IODINE | 85H0HZU99M | ACTIM |
| HYDROXYETHYL CELLULOSE, UNSPECIFIED | T4V6TWG28D | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1100b895-e9b7-42f9-b787-c41d102e92a5 | a9ee4c33-4a5b-3a1f-e053-2995a90aa515 | 2020-11-13 | Warnings | 1100b895-e9b7-42f9-b787-c41d102e92a5 a9ee4c33-4a5b-3a1f-e053-2995a90aa515 |
Adverse event summaries are temporarily unavailable. Other product information remains available.