OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20%
Menthol 0.5%
Zinc Chloride 0.15%
Benzocaine 20%
Menthol 0.5%
Zinc Chloride 0.15%
Oral pain reliever
Oral pain reliever
Astringent
for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums
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 that 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 * allergice reaction occurs
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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 between 2 and 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 tip 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
blue 1, cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2117335 | benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral Gel | PSN | 1 |
| 2117335 | benzocaine 0.2 MG/MG / menthol 0.005 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel | SCD | 1 |
| 2117335 | benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral Gel | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-389-99 | 2023-01-30 | C162847 | 48780-1 | f386c649-c300-0266-e053-dadaa90a7c1a | TopCare 3x Medicated OP Gel |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-389-99 | Severe Triple Medicated Gel | 7 g in 1 TUBE | GEL | 7 | 1 | |
| 36800-389-99 | Severe Triple Medicated Gel | 1 in 1 CARTON | GEL | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-389 | 36800-389-99 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| PECTIN | 89NA02M4RX | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| SACCHARIN SODIUM | SB8ZUX40TY | 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 |
|---|---|---|---|---|---|---|
| b43ff7a4-dd47-d7d4-e053-2995a90a49f1 | b43ff7a4-dd46-d7d4-e053-2995a90a49f1 | 2020-11-16 | Warnings | b43ff7a4-dd47-d7d4-e053-2995a90a49f1 b43ff7a4-dd46-d7d4-e053-2995a90a49f1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.