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#

ProductCVS Maximum Toothache Relief Double Medicated
Active ingredientMENTHOL, BENZOCAINE
Label structure10 sections

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)

CVS_MaxStrength_Gel_.25CTN_F8015374CVS_MaxStrength_Gel_.25CTN_F8015374

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-35469842-354-79, 69842-354-89, 69842-354-99

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c73efe35-827a-3e14-e053-2a95a90a7c9e81909b3a-36fa-3861-e053-2991aa0a5d162021-07-16WarningsExact identifier
spl id: c73efe35-827a-3e14-e053-2a95a90a7c9e
spl set id: 81909b3a-36fa-3861-e053-2991aa0a5d16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.