4X Medicated Severe Toothache and Gum Cream

Manufacturer
Rite Aid | Lornamead Products
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:16:10

Label at a glance#

Product4X Medicated Severe Toothache and Gum Cream
Active ingredientBENZOCAINE, MENTHOL, ZINC CHLORIDE, BENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Directions * cut open tip of tube on score mark * dults and children 2 years of age and older; apply a small amount of product to the cavity and around teh 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Belkonium chloride 0.13% .... Oral antiseptic

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

Menthol 0.26% ...................... Oral pain reliever

Zinc chloride 0.15% ............... Oral astringent

Use

OTC - PURPOSE SECTION

Use * for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

INDICATIONS & USAGE SECTION

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces teh 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

WARNINGS SECTION

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 * symtoms 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions * cut open tip of tube on score mark * dults and children 2 years of age and older; apply a small amount of product to the cavity and around teh 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 the tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use continuously * this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton R2Carton R2

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 CreamPSN14
2370903benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral CreamSCD14
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamSY14

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
11822-0614-94X Medicated Severe Toothache and Gum Cream1 in 1 CARTONCREAM114
11822-0614-94X Medicated Severe Toothache and Gum Cream9.4 g in 1 TUBECREAM9.414

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-061411822-0614-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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
4X Medicated Severe Toothache and Gum CreamBENZOCAINERite Aid996fdbeb-1fe3-77b6-e053-2995a90a25c72025-11-13WarningsExact identifier
ndc (package): 11822-0614-9
ndc (product): 11822-0614
ndc11 (package): 11822061409
spl id: 437ff1ad-5461-e55c-e063-6394a90a258b
spl set id: 996fdbeb-1fe3-77b6-e053-2995a90a25c7

Reported adverse events (FAERS/openFDA)#

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