Toothache and Gum Relief Cushions

Manufacturer
Rite Aid | Lornamead | Lornamead Products
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:17:36

Label at a glance#

ProductToothache and Gum Relief Cushions
Active ingredientMENTHOL, BENZOCAINE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 10% . . . Oral pain reliever

Menthol 0.25% . . . Oral pain reliever

OTC - PURPOSE SECTION

INDICATIONS & USAGE SECTION

for the temporary relief of pain due to toothaches

WARNINGS SECTION

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 develop: * 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

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

Stop use and ask a doctor if * swelling, rash or fever develops * iffitation, 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

carefully remove gel cushion from blister. Gently mold with fingers until soft. Apply to the affected tooth/gum area and gently press for 5-10 seconds to mold for a comfortable fit. Gel cushion will stay in place and dissolve slowly in mouth. Adults and children 12 years of age and older: use up to 3 times daily or as directed by a dentist or doctor. Children under 12 years of age: ask a dentist or doctor. Children under 2 years of age: do not use

OTHER SAFETY INFORMATION

Do not use if blister card is broken. 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. These toothache cushions are designed to completely dissolve in place. Store at room temperature 15-30°C (59-86°F)

INACTIVE INGREDIENT SECTION

cellulose gum, flavor, polyethylene glycol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton R2Carton R2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1616-9Toothache and Gum Relief Cushions0.5 g in 1 BLISTER PACKDRESSING0.56
11822-1616-9Toothache and Gum Relief Cushions8 in 1 CARTONDRESSING86

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-161611822-1616-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
Toothache and Gum Relief CushionsBENZOCAINERite Aid9970d485-0b78-1438-e053-2995a90ad32c2025-11-21WarningsExact identifier
ndc (package): 11822-1616-9
ndc (product): 11822-1616
ndc11 (package): 11822161609
spl id: 441ec368-d742-cc10-e063-6394a90a6c66
spl set id: 9970d485-0b78-1438-e053-2995a90ad32c

Reported adverse events (FAERS/openFDA)#

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