3x Medicated Mouth Sore Gel

Manufacturer
HEB | Lornamead | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-06-03 17:52:11

Label at a glance#

Product3x Medicated Mouth Sore Gel
Active ingredientMENTHOL, UNSPECIFIED FORM, BENZOCAINE, ZINC CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Benzocaine 20% . . . . . .Oral pain reliever

Menthol 0.1% . . . . . . . . Oral pain reliever

Zinc chloride 0.15% . . . .Oral astringent

WARNINGS SECTION

Methemoglobinemia warning: use of this product may cause methoglobinemia, 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

USER SAFETY WARNINGS 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

OTHER SAFETY INFORMATION

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

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritaiton, pain or redness persists or worsens

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.

INACTIVE INGREDIENT SECTION

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

OTC - QUESTIONS SECTION

Questions and Comments? Call 1-877-7777-2743

OTC - PURPOSE SECTION

for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

INDICATIONS & USAGE SECTION

Directions

  • cut open tip of tube on score mark
  • do not use if tip is cut prior to opening
  • adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor.
  • Children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
  • children under 2 years of age: do not use

DOSAGE & ADMINISTRATION SECTION

  • cut open tip of tube on score mark
  • do not use if tip is cut prior to opening
  • adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor.
  • Children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
  • children under 2 years of age: do not use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEB_3xmedicated_mouthsoregel_2821619R2HEB_3xmedicated_mouthsoregel_2821619R2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2266762benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral GelPSN6
2266762benzocaine 0.2 MG/MG / menthol 0.001 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCD6
2266762benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral GelSY6

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041220331512GTIN-13: 0041220331512
EAN-13: 0041220331512
GTIN-12: 041220331512
UPC-A: 041220331512
GTIN storage (14 digits): 00041220331512
HEB_3XMedicated_MouthsoreGel_CtnCF_2821619R2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-691-193x Medicated Mouth Sore Gel1 in 1 CARTONGEL16
37808-691-193x Medicated Mouth Sore Gel9.4 g in 1 TUBEGEL9.46

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-69137808-691-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-08-08full-release2026-06-01 01:09:49

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
3x Medicated Mouth Sore GelBENZOCAINEHEBa71c5259-cbd1-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
ndc (package): 37808-691-19
ndc (product): 37808-691
ndc11 (package): 37808069119
spl id: 47e54275-5f0e-b73b-e063-6294a90a7a8c
spl set id: a71c5259-cbd1-7566-e053-2995a90a2cb6

Reported adverse events (FAERS/openFDA)#

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