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#

Productequate Severe Toothache and Gum Relief
Active ingredientBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

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

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-361-192020-06-26C16284748780-19d75b9d1-2433-f424-e053-dadaa90a57ce5820361 equate Severe Toothache & Gum Relief
49035-361-192020-01-31C16284748780-19d75b9d1-2433-f424-e053-dadaa90a57ce5820361 equate Severe Toothache & Gum Relief

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-36149035-361-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
c73ef91b-f5ee-4ba6-e053-2a95a90ade94799d957b-4510-5507-e053-2991aa0ad60d2021-07-16WarningsExact identifier
spl id: c73ef91b-f5ee-4ba6-e053-2a95a90ade94
spl set id: 799d957b-4510-5507-e053-2991aa0ad60d

Reported adverse events (FAERS/openFDA)#

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