SPL UNCLASSIFIED SECTION
Drug Facts
Rite Aid Triple Medicated Severe Toothache & Gum Relief Cream
- Manufacturer
- Rite Aid | Lornamead Inc.
- Effective date
- 2023-01-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:40:49
Label at a glance#
ProductRite Aid Severe Toothache and Gum Relief Triple Medicated
Active ingredientZINC CHLORIDE, MENTHOL, BENZOCAINE
Label structure10 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Benzocaine 20%
Menthol 0.25%
Zinc Chloride 0.15%
OTC - PURPOSE SECTION
Purpose
Oral pain reliever
Oral pain reliever
Astringent
INDICATIONS & USAGE SECTION
Use
- for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums
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
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 directed 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 under 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, petrolatum, polyethylene glycol, sodium saccharin
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY:
RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
TAMPER EVIDENT: Carton is sealed for your protection.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
RITE AID® PHARMACY
SEVERE toothache & gum relief
ORAL PAIN RELIEVER; ASTRINGENT
immediate relief of intense pain
Long lasting CREAM
triple medicated
- 20% Benzocaine for toothache pain relief
- Astringent to relieve gum irritation
- Menthol to soothe gums
NET WT 0.33 OZ (9.4g)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-6037-9 | 2025-11-21 | C162847 | 48780-1 | 2cef2736-a67c-d83d-e063-dadaa90ab31f | Rite Aid Triple Medicated Severe Toothache & Gum Relief Cream |
| 11822-6037-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a67c-d83d-e063-dadaa90ab31f | Rite Aid Triple Medicated Severe Toothache & Gum Relief Cream |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-6037 | RITE AID SEVERE TOOTHACHE AND GUM RELIEF TRIPLE MEDICATED (BENZOCAINE, MENTHOL, ZINC CHLORIDE) CREAM [RITE AID] | 10 | Legacy NDC | 20230112_83484515-49a1-110c-e053-2991aa0a161b.zip |
Products#
Every source-derived product name is available through these pages.
- Rite Aid Severe Toothache and Gum Relief Triple Medicated
- Benzocaine, Menthol, Zinc chloride
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- PETROLATUM
- MINERAL OIL
- PECTIN
- GELATIN
- SACCHARIN SODIUM
- SACCHARIN
- METHYL SALICYLATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- ZINC CHLORIDE
- ZINC CATION
- MENTHOL
- BENZOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11822-6037 | 11822-6037-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PECTIN | 89NA02M4RX | IACT |
| GELATIN | 2G86QN327L | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
| MENTHOL | L7T10EIP3A | ACTIB |
| BENZOCAINE | U3RSY48JW5 | 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 |
|---|---|---|---|---|---|---|
| 441ec368-d743-cc10-e063-6394a90a6c66 | 83484515-49a1-110c-e053-2991aa0a161b | 2025-11-21 | Warnings | 83484515-49a1-110c-e053-2991aa0a161b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.