4x Medicated Toothache and Gum Cream

Manufacturer
HEB | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-06-03 17:52:38

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose Benzalkonium chloride 0.13% . . . Oral antiseptic Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever Menthol 0.26% . . . . . . . . . . . . . . .Oral pain reliever Zinc chloride 0.15% . . . . . . . . . . .Oral astringent

OTC - PURPOSE SECTION

Oral antiseptic Oral pain reliever Oral pain reliever Oral astringent

Warnings

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 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 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

Directions And Dosage

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: ask doctor before use. Should be supervised in the use of this product children under 2 years of age: do not use

Other Label Information

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

Label Images#

HEB_4XMedicated_ToothacheCream_CtnCF_2821611R2
HEB_4XMedicated_ToothacheCream_CtnCF_2821611R2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamPSN6
2370903benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral CreamSCD6
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamSY6

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-116-694x Medicated Toothache and Gum Cream9.4 g in 1 TUBECREAM9.46
37808-116-694x Medicated Toothache and Gum Cream1 in 1 CARTONCREAM16

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-11637808-116-69

Ingredients#

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose Benzalkonium chloride 0.13% . . . Oral antiseptic Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever Menthol 0.26% . . . . . . . . . . . . . . .Oral pain reliever Zinc chloride 0.15% . . . . . . . . . . .Oral astringent

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Oral antiseptic Oral pain reliever Oral pain reliever Oral astringent

WARNINGS SECTION

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 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 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

DOSAGE & ADMINISTRATION SECTION

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: ask doctor before use. Should be supervised in the use of this product children under 2 years of age: do not use

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Other information do not use if tip is cut prior to opening avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Source Document#

Source XML

Older Hydrated Versions#

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