OTC - ACTIVE INGREDIENT SECTION
Benzocaine
Menthol
Benzocaine
Menthol
Oral pain reliever
Oral pain reliever
fo rthe temporary relief of pain due to: * canker sores * minor injury of the mouth and gums * minor irritation of the mouth and gums caused by dentures
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a 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 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.
do not use if package has been opened * adults and children 2 years of age and older: using applicator tip, apply to the cavity and around the gum surrounding the tooth. 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
this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continually.
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 |
|---|---|---|---|---|---|
| 49354-353-39 | 2023-01-30 | C162847 | 48780-1 | f386c649-d226-0266-e053-dadaa90a7c1a | 5820353 CVS 2x Liq (CSR) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49354-353-39 | CVS 2x Liq (CSR) | 14.7 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 14.7 | 1 | |
| 49354-353-39 | CVS 2x Liq (CSR) | 1 in 1 CARTON | LIQUID | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49354-353 | 49354-353-39 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | 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 |
|---|---|---|---|---|---|---|
| cb07e62a-27b2-570c-e053-2995a90a7dce | cb07e62a-27b1-570c-e053-2995a90a7dce | 2021-09-02 | Warnings | cb07e62a-27b2-570c-e053-2995a90a7dce cb07e62a-27b1-570c-e053-2995a90a7dce |
Adverse event summaries are temporarily unavailable. Other product information remains available.