FDA.reportPublic FDA data

HEB Mouth Sore Relief Triple Med Gel

Manufacturer
HEB | Lornamead Inc.
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 23:53:08

Label at a glance#

ProductHEB Mouth Sore Relief
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE, ZINC CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.02%

Benzocaine 20%

Zinc chloride 0.1%

OTC - PURPOSE SECTION

Purpose

Oral Antiseptic

Oral Pain Reliever

Oral Astringent

INDICATIONS & USAGE SECTION

Uses

temporarily relieves of pain caused by:

  • canker sores
  • cold sores
  • fever blisters
  • minor irritation of the mouth and gums
  • to help protect against infection in 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 the 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 persist or worsen
  • sore mouth 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 to affected area 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

INACTIVE INGREDIENT SECTION

Inactive ingredients Allantoin,Carbomer, Edetate Disodium, Mentha Piperata (Peppermint Oil), Polyethylene Glycol, Polysorbate 60, Propylene Glycol, Propyl Gallate, Purified Water, PVP, Sodium Saccharin, Sorbic Acid, Stearyl Alcohol.

OTC - QUESTIONS SECTION

Questions or Comments? Call 1-877-777-2473

SPL UNCLASSIFIED SECTION

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H-E-B

MOUTH SORE RELIEF

FAST-ACTING GEL

TRIPLE MEDICATED

ORAL PAIN RELIEVER/ANTISEPTIC/ASTRINGENT

NET WT 0.42 OZ (11.9 g)

HEB MOUTH SORE GEL 2821343-1R2HEB MOUTH SORE GEL 2821343-1R2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1042836benzalkonium chloride 0.02 % / benzocaine 20 % / zinc chloride 0.1 % Oral GelPSN10
1042836benzalkonium chloride 0.0002 MG/MG / benzocaine 0.2 MG/MG / zinc chloride 0.001 MG/MG Oral GelSCD10
1042836benzalkonium chloride 0.02 % / benzocaine 20 % / zinc chloride 0.1 % Oral GelSY10

DailyMed Pharmacologic Classes#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-312-292025-01-30C16284748780-12cef2736-acaa-d83d-e063-dadaa90ab31fHEB Mouth Sore Relief Triple Med Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-312-29HEB Mouth Sore Relief1 in 1 CARTONGEL110
37808-312-29HEB Mouth Sore Relief11.9 g in 1 TUBEGEL11.910

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-312HEB MOUTH SORE RELIEF (BENZALKONIUM CHLORIDE, BENZOCAINE, ZINC CHLORIDE) GEL [HEB]10Legacy NDC, 2 package rows20230112_8246a419-f8b1-4d99-e053-2991aa0ac4ac.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-31237808-312-29

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYSORBATE 60CAL22UVI4MIACT
ALLANTOIN344S277G0ZIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBIC ACIDX045WJ989BIACT
PEPPERMINT OILAV092KU4JHIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
EDETATE DISODIUM7FLD91C86KIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYL GALLATE8D4SNN7V92IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
BENZOCAINEU3RSY48JW5ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ZINC CHLORIDE86Q357L16BACTIM

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
f202ed09-ce2d-6f27-e053-2a95a90ad8948246a419-f8b1-4d99-e053-2991aa0ac4ac2023-01-11WarningsExact identifier
spl id: f202ed09-ce2d-6f27-e053-2a95a90ad894
spl set id: 8246a419-f8b1-4d99-e053-2991aa0ac4ac

Reported adverse events (FAERS/openFDA)#

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