Adults and children 12 years and over. Press top of container and dispense 0.2 mL. Apply 0.2 mL of gel to the desired area using a cotton swab. Children under 12 should be supervised by an adult. Children under 2 years of age, consult a doctor.
Store at room temperature 20˚-25˚ C (68˚ - 77˚ F). Protect from freezing.
Benzocaine 20%
Oral Anesthetic
Temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic devices
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a rare but serious condition that must 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 they or a child in your care develops:
Do not exceed reccommended dosage
Do not use if you have a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other ‘caine’ anesthetics
Do not use for more than 7 days unless directed by a doctor or dentist
Stop using and ask a doctor if swelling, rash or fever develops or if irritation, pain or redness persists of gets worse
Do not exceed recommended dosage.
Keep out of reach of children. In case of overdose, get medical help or Contact Poison Control Center right away
Do not use
Adults and children 12 years and over. Press top of container and dispense 0.2 mL. Apply 0.2 mL of gel to the desired area using a cotton swab.
Children under 12 should be supervised by an adult.
Children under 2 years of age, consult a doctor.
Store at room temperature
20˚-25˚ C (68˚ - 77˚ F).
Protect from freezing.
Propylene glycol, polyethylene glycol, carbomer, sodium saccharin, povidone, ethyl alcohol, methylparaben, propyl paraben, flavoring, D&C Yellow No. 10 and FD&C Blue No. 1.
Contact Hager Worldwide at (800) 328-2335
NDC 62565-801-01
OneTouch
Revolution
Topical Anesthetic Gel
ORAL pain relief for teeth and accessible mucous membrane.
Cool Mint
Net Wt. 1.12 oz (32 g)
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62565-801-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e6a7-f424-e053-dadaa90a57ce | OneTouch Revolution Topical Anesthetic Gel Cool Mint Flavor |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62565-801-01 | OneTouch RevolutionTopical Anesthetic | 32 g in 1 JAR | GEL | 32 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 62565-801 | 62565-801-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| CARBOXYPOLYMETHYLENE | 0A5MM307FC | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | 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 |
|---|---|---|---|---|---|---|
| 318f5665-8e65-465b-a231-9e273025bc9e | 39e2490d-09f4-42e7-98d1-bd9f0120dc63 | 2018-07-15 | Warnings | 318f5665-8e65-465b-a231-9e273025bc9e 39e2490d-09f4-42e7-98d1-bd9f0120dc63 |
Adverse event summaries are temporarily unavailable. Other product information remains available.