Storage and handling
Other Information • Not made with natural rubber latex • Store at room temperature; avoid excessive heat
Other Information • Not made with natural rubber latex • Store at room temperature; avoid excessive heat
Povidone-Iodine USP, 1.25%
(0.125% Available Iodine)
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
| 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 |
|---|---|---|---|---|---|
| 78371-401-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-fd53-a426-e053-dadaa90af4c2 | Halodine Oral Antiseptic Spray |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78371-401-01 | Halodine Oral Antiseptic | 60 mL in 1 BOTTLE, SPRAY | SPRAY | 60 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 78371-401 | 78371-401-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE-IODINE | 85H0HZU99M | ACTIM |
| HYDROXYETHYL CELLULOSE, UNSPECIFIED | T4V6TWG28D | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| 2ca898e7-199b-487d-802d-b662ab2a2db2 | 0c834b76-f367-4550-9b4e-82ade5df7094 | 2020-10-14 | Warnings | 2ca898e7-199b-487d-802d-b662ab2a2db2 0c834b76-f367-4550-9b4e-82ade5df7094 |
Adverse event summaries are temporarily unavailable. Other product information remains available.