OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20%
Menthol 0.1%
Benzocaine 20%
Menthol 0.1%
Oral anesthetic
Oral anesthetic
temporarily relieves pain associated with the following mouth and gum irritations: * toothache * sore gums * canker sores * braces * minor dental procedures
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated prompty 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: * pale, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue or lack of energy
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
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 * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adults and children 2 years of age and older: * apply to affected area using applicator tip * use up to 4 times daily or as directed by a 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
do not use if package has been opened * store ar 20-25°C (68-77°F)
alcohol, flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49354-375-08 | 2023-01-30 | C162847 | 48780-1 | f386c649-b6b6-0266-e053-dadaa90a7c1a | 5820375 CVS 2x Med Liq (CSR) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49354-375-08 | 2x Med Liq | 14.7 mL in 1 BOTTLE, GLASS | LIQUID | 14.7 | 1 | |
| 49354-375-08 | 2x Med Liq | 1 in 1 CARTON | LIQUID | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49354-375 | 49354-375-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
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 |
|---|---|---|---|---|---|---|
| cb078678-71a6-b494-e053-2a95a90a9d60 | cb078e07-4c38-7d3d-e053-2995a90a2934 | 2021-09-02 | Warnings | cb078678-71a6-b494-e053-2a95a90a9d60 cb078e07-4c38-7d3d-e053-2995a90a2934 |
Adverse event summaries are temporarily unavailable. Other product information remains available.