SPL UNCLASSIFIED SECTION
Drug Facts
HEB Severe Toothache & Gum Relief Triple Medicated Cream
- Manufacturer
- HEB | Lornamead Inc.
- Effective date
- 2023-01-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-05-31 23:53:08
Label at a glance#
ProductHEB Severe Toothache and Gum Relief Triple Medicated
Active ingredientBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL
Label structure10 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Benzocaine 20%
Menthol 0.25%
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
Methemoglobenemia 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
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 the 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 ingredientscellulose gum, gelatin, methyl salicylate, mineral oil, pectin, polyethylene glycol, sodium saccharin
SPL UNCLASSIFIED SECTION
MADE WITH PRIDE AND CARE FOR H-E-B®
SAN ANTONIO, TX 78204
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
H-E-B®
LONG LASTING CREAM
SEVERE TOOTHACHE & GUM RELIEF
ORAL PAIN RELIEVER
ANTISEPTIC
TRIPLE MEDICATED
- 20% Benzocaine for toothache pain relief
- Antiseptic to help prevent infection
- Soothing Menthol for gums
NET WT 0.33 OZ (9.3 g)
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37808-313-49 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6fbd-d83d-e063-dadaa90ab31f | HEB Severe Toothache & Gum Relief Triple Medicated Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-313-49 | HEB Severe Toothache and Gum ReliefTriple Medicated | 1 in 1 CARTON | CREAM | 1 | 10 | |
| 37808-313-49 | HEB Severe Toothache and Gum ReliefTriple Medicated | 9.3 g in 1 TUBE | CREAM | 9.3 | 10 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- HEB Severe Toothache and Gum Relief Triple Medicated
- Benzalkonium chloride, Benzocaine, Menthol
- GELATIN
- METHYL SALICYLATE
- MINERAL OIL
- PETROLATUM
- PECTIN
- SACCHARIN SODIUM
- SACCHARIN
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- POLYETHYLENE GLYCOL, UNSPECIFIED
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
- BENZOCAINE
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37808-313 | 37808-313-49 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GELATIN | 2G86QN327L | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| PECTIN | 89NA02M4RX | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | 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 |
|---|---|---|---|---|---|---|
| f2030113-fc98-6bee-e053-2995a90a10f6 | 82586cb7-797c-e239-e053-2a91aa0af79c | 2023-01-11 | Warnings | f2030113-fc98-6bee-e053-2995a90a10f6 82586cb7-797c-e239-e053-2a91aa0af79c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.