equate Severe Toothache and Gum Relief
- Manufacturer
- Wal-Mart Stores Inc | Lornamead
- Effective date
- 2021-07-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:40:24
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Benzocaine 20%
Menthol 0.5%
Benzalkonium Chloride 0.1%
OTC - PURPOSE SECTION
Purpose
Oral pain reliever
Oral pain reliever
Antiseptic
INDICATIONS & USAGE SECTION
Use · for the temporary relief of pain due to toothaches · to help protect against infection of minor oral irritation
WARNINGS SECTION
Warnings
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
SPL UNCLASSIFIED SECTION
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
OTC - DO NOT USE SECTION
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
OTC - STOP USE SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 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
OTHER SAFETY INFORMATION
Other information • 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
INACTIVE INGREDIENT SECTION
Inactive ingredients Blue 1, Cellulose Gum, Gelatin, Methyl Salicylate, Mineral Oil, Pectin, Petrolatum,
Polyethylene Glycol, Sodium Saccharin
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
equate
Triple Medicated
Severe Toothache
& Gum Relief
Oral Pain Reliever / Antiseptic
Immediate Relief of Intense Pain
- Maximum strength BENZOCAINE for toothache pain relief
- Antiseptic to help prevent infection
- Soothing menthol for gums
Fast Acting Gel
Compare to Orajel™ Severe Triple Medicated Gel Active Ingredients*
Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.
DISTRIBUTED BY: Wal-Mart Stores, Inc. Bentonville, AR 72716
*This product is not manufactured or distributed by Church & Dwight Co. Inc., makers of Orajel™.
TAMPER-EVIDENT:
Do not use if tube tip is cut prior to use
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49035-361-19 | 2020-06-26 | C162847 | 48780-1 | 9d75b9d1-2433-f424-e053-dadaa90a57ce | 5820361 equate Severe Toothache & Gum Relief |
| 49035-361-19 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2433-f424-e053-dadaa90a57ce | 5820361 equate Severe Toothache & Gum Relief |
Products#
Every source-derived product name is available through these pages.
- equate Severe Toothache and Gum Relief
- benzocaine, menthol, benzalkonium chloride
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- PECTIN
- GELATIN
- MINERAL OIL
- FD&C BLUE NO. 1
- PETROLATUM
- SACCHARIN SODIUM
- SACCHARIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- METHYL SALICYLATE
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
- BENZOCAINE
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49035-361 | 49035-361-19 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| PECTIN | 89NA02M4RX | IACT |
| GELATIN | 2G86QN327L | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| c73ef91b-f5ee-4ba6-e053-2a95a90ade94 | 799d957b-4510-5507-e053-2991aa0ad60d | 2021-07-16 | Warnings | c73ef91b-f5ee-4ba6-e053-2a95a90ade94 799d957b-4510-5507-e053-2991aa0ad60d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
