OTC - ACTIVE INGREDIENT SECTION
Benzalkonium chloride 0.13% . . . Oral antiseptic
Benzocaine 20% . . . Oral pain reliever
Menthol 0.5% . . . Oral pain reliever
Zinc chloride 0.15% . . . Oral astringent
Benzalkonium chloride 0.13% . . . Oral antiseptic
Benzocaine 20% . . . Oral pain reliever
Menthol 0.5% . . . Oral pain reliever
Zinc chloride 0.15% . . . Oral astringent
Use * for the temporary relief of pain due to toothaches * to help prevent against infection of minor oral irritation
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 immeditate 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.
Directions * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. 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
Other inforation * do not use if tip of tube is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use continuously * this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62721-5602-9 | 2023-01-30 | C162847 | 48780-1 | f386c649-9faf-0266-e053-dadaa90a7c1a | 8015602 4x Med Gel |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 62721-5602 | 62721-5602-9 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| 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 |
|---|---|---|---|---|---|---|
| a757d0d5-24a5-611b-e053-2a95a90adf19 | a757d0d5-24a4-611b-e053-2a95a90adf19 | 2020-06-05 | Warnings | a757d0d5-24a5-611b-e053-2a95a90adf19 a757d0d5-24a4-611b-e053-2a95a90adf19 |
Adverse event summaries are temporarily unavailable. Other product information remains available.