5820374 CVS Double Medicated Maximum Toothache Relief Gel
- Manufacturer
- CVS Pharmacy | Lornamead Inc.
- Effective date
- 2021-07-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:40:25
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Benzocaine 20%
Menthol 0.26%
OTC - PURPOSE SECTION
Purpose
Oral pain reliever
Oral Pain reliever
INDICATIONS & USAGE SECTION
Use
- for the temporary relief of 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 ingredientsammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: Do not use if tube tip is cut prior to use.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2019 CVS/pharmacy
CVS.com 1-800-SHOP CVS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CVS Health™
MAXIMUM PAIN RELIEF
Toothache Relief Gel
ORAL PAIN RELIEVER
DOUBLE MEDICATED
- 20% BENZOCAINE to relieve oral pain
- MENTHOL to soothe
NET WT 0.25 OZ (7g)
Products#
Every source-derived product name is available through these pages.
- CVS Maximum Toothache Relief Double Medicated
- Benzocaine, Menthol
- SACCHARIN SODIUM
- SACCHARIN
- SORBIC ACID
- AMMONIUM GLYCYRRHIZATE
- GLYCYRRHIZIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- MENTHOL
- BENZOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-354 | 69842-354-79, 69842-354-89, 69842-354-99 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| 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 |
|---|---|---|---|---|---|---|
| c73efe35-827a-3e14-e053-2a95a90a7c9e | 81909b3a-36fa-3861-e053-2991aa0a5d16 | 2021-07-16 | Warnings | c73efe35-827a-3e14-e053-2a95a90a7c9e 81909b3a-36fa-3861-e053-2991aa0a5d16 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
