5820342 TopCare Max Str Oral Pain Relief Gel

Manufacturer
Topco Associates LLC | Lornamead Products
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:16:08

Label at a glance#

ProductTopCare Oral Pain Relief Maximum Strength
Active ingredientBENZOCAINE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine 20%

OTC - PURPOSE SECTION

Purpose

Oral Pain Reliever

INDICATIONS & USAGE SECTION

Use

  • for the temporary relief of pain due to toothaches

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 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, 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 scoremark
  • adults and children 2 years of age and older: apply a small amount of product to the cavity and around the 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 tempory expedient until a dentist can be consulted
  • do not use continuously

INACTIVE INGREDIENT SECTION

Inactive ingredients flavor, polyethylene glycol, sodium saccharin, sorbic acid

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60057

QUESTIONS" 1-888-423-0139

topcare@topco.com www.topcarebrand.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton R4Carton R4

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
36800-512-29TopCare Oral Pain ReliefMaximum Strength14 g in 1 TUBEGEL1414
36800-512-29TopCare Oral Pain ReliefMaximum Strength1 in 1 CARTONGEL114

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
36800-51236800-512-29

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
TopCare Oral Pain Relief Maximum StrengthBENZOCAINETopco Associates LLC835fb6ac-dbb7-5566-e053-2991aa0af5e22025-11-13WarningsExact identifier
ndc (package): 36800-512-29
ndc (product): 36800-512
ndc11 (package): 36800051229
spl id: 437fcc59-02bc-7d8c-e063-6394a90af1c0
spl set id: 835fb6ac-dbb7-5566-e053-2991aa0af5e2

Reported adverse events (FAERS/openFDA)#

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