Indications and uses
Uses: Temporarily relieves pain caused by toothache, canker, sores, cold sores, fever blisters, minor irritation or injury of the moth and gums.
Uses: Temporarily relieves pain caused by toothache, canker, sores, cold sores, fever blisters, minor irritation or injury of the moth and gums.
Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by dentist or doctor Children under 12 years of age | Should be supervised in the use of this product Children under 2 years of age | Do not use Directions: Spray a small amount of product around the affected area up to 4 times daily.
Active Ingredients: Purpose
Benzocaine 20%............................... Oral Pain Reliever
Uses: Temporarily relieves pain caused by toothache, canker, sores, cold sores, fever blisters, minor irritation or injury of the moth and gums.
Warnings: Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condiiton tha tmust be treated promptly, because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops pal, gray, or blue colored skin cyanosis), headache, rapid heartbeat, shortness of breath, diziness or lightheadedness, fatigue or lack of enerygy. Keep away from eyes.
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. If a skin reaction occurs, stop use and seek medical attention right away.
Flammability warning: keep away from fire or flame
Do not use: more than directed, for more than 7 days unless told to do so by a dentist or doctor, for teething, in children under 2 years of age.
Stop use and ask a doctor if: sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, pain or redness persists or worsens.
If pregnant or breastfeeding, ask a health professional before use
keep out of rech of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by dentist or doctor | |
| Children under 12 years of age | Should be supervised in the use of this product | |
| Children under 2 years of age | Do not use |
Directions: Spray a small amount of product around the affected area up to 4 times daily.
Other information: Store at controlled room temperature: 15-30ºC (59-86ºF). Tamper Evident Feature: Do not use if cello-band over cap is torn, broken or missing.
Inactive ingredients: alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium methylparaben, sodium saccharin
Change in section type from directions to indications and useage
Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by dentist or doctor
Children under 12 years of age | Should be supervised in the use of this product
Children under 2 years of age | Do not use
Directions: Spray a small amount of product around the affected area up to 4 times daily.
Dentarin
Balsamo Dental En Spray
Helps relieve Toothache and Mouth Sores
Net Contents: 1 Fl. Oz (30mL)
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69469-200-30 | Dentarin | 30 mL in 1 BOTTLE, SPRAY | SOLUTION | 30 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69469-200 | 69469-200-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CLOVE OIL | 578389D6D0 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| METHYLPARABEN SODIUM | CR6K9C2NHK | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| ALCOHOL | 3K9958V90M | 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 |
|---|---|---|---|---|---|---|
| 20b39f18-0b8e-9f01-e063-6394a90a213e | 20b39f18-0b8d-9f01-e063-6394a90a213e | 2024-08-27 | Warnings | 20b39f18-0b8e-9f01-e063-6394a90a213e 20b39f18-0b8d-9f01-e063-6394a90a213e |
Adverse event summaries are temporarily unavailable. Other product information remains available.