5820630 Rite Aid Max Str Oral Pain Relief Gel (8015316)

Manufacturer
Rite Aid | Lornamead Inc.
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:52:57

Label at a glance#

ProductRite Aid Maximum Strength
Active ingredientBENZOCAINE
Label structure10 sections

Storage and handling

Other information store at 20-25°C (68-77°F). Do not refrigerate.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine 20%

OTC - PURPOSE SECTION

Purpose

Oral anesthetic

INDICATIONS & USAGE SECTION

Use

temporarily relieves pain associated with mouth and gum irritations

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 of 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 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

  • to open tube, cut tip of tube on score mark
  • adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by dentist/doctor
  • children under 12 years of age: adult supervision should be given in the use of this product
  • children under 2 years of age: do not use
  • for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting

STORAGE AND HANDLING SECTION

Other information

store at 20-25°C (68-77°F). Do not refrigerate.

INACTIVE INGREDIENT SECTION

Inactive ingredients Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RITE AID® PHARMACY

MAXIMUM STRENGTH

oral pain relief

benzocaine 20%

anesthetic gel

instant pain relief for:

toothaches

gum pain

canker sores

denture pain

NET WT 0.33 OZ (9 g)

RA ORAL ANALGESIC GEL 2824366R2RA ORAL ANALGESIC GEL 2824366R2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN14
238910benzocaine 0.2 MG/MG Oral GelSCD14
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY14

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0316-4Rite AidMaximum Strength1 in 1 CARTONGEL, DENTIFRICE114
11822-0316-4Rite AidMaximum Strength9 g in 1 TUBEGEL, DENTIFRICE914

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0316RITE AID MAXIMUM STRENGTH (BENZOCAINE) GEL, DENTIFRICE [RITE AID]14Current NDC, Legacy NDC, 2 package rows20250119_13effad7-f363-b7fc-e063-6394a90a114c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-031611822-0316-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Maximum StrengthBENZOCAINERite Aid5e216587-5384-464a-a4dd-07943668cabd2025-11-21WarningsExact identifier
ndc (product): 11822-0316
2bedc5eb-1ab8-138c-e063-6394a90aea7c13effad7-f363-b7fc-e063-6394a90a114c2025-01-17WarningsExact identifier
spl id: 2bedc5eb-1ab8-138c-e063-6394a90aea7c
spl set id: 13effad7-f363-b7fc-e063-6394a90a114c

Reported adverse events (FAERS/openFDA)#

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