Red Cross Canker Sore

Manufacturer
The Mentholatum Company
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:12

Label at a glance#

ProductRed Cross Canker Sore
Active ingredientBENZOCAINE
Label structure8 sections

Indications and uses

temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures

Dosage and administration

snip off tip of tube apply to affected area; carefully coat with a protective layer supervise children using this product adults and children 2 years and over: use up to 4 times daily or as directed by a doctor children under 2 years: do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral anesthetic/analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures

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

OTC - DO NOT USE SECTION

  • for teething
  • in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

  • do not use for more than 7 days unless directed by a dentist or doctor
  • do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • sore mouth symptoms last more than 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • snip off tip of tube
  • apply to affected area; carefully coat with a protective layer
  • supervise children using this product
  • adults and children 2 years and over: use up to 4 times daily or as directed by a doctor
  • children under 2 years: do not use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, butylated hydroxytoluene, carbomer hompolymer, cetylpyridinium chloride, chamomilla recutita (matricaria) flower extract, cocos nucifera (coconut) oil, commiphora myrrha resin, dimethicone, echinacea purpurea extract, flavor, glyceryl stearate, menthol, mineral oil, silica dimethicone silylate, vitamin E, white petrolatum

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Red Cross Canker Sore Oral Anesthetic/Analgesic
Red Cross Canker Sore Oral Anesthetic/Analgesic

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244323benzocaine 20 % Oral OintmentPSN4
1489070Red Cross Canker Sore 20 % Oral OintmentPSN4
1489070benzocaine 0.2 MG/MG Oral Ointment [Red Cross Canker Sore]SBD4
244323benzocaine 0.2 MG/MG Oral OintmentSCD4
244323benzocaine 20 % Oral OintmentSY4
1489070Red Cross Canker Sore 0.2 MG/MG Oral OintmentSY4
1489070Red Cross Canker Sore 20 % Oral OintmentSY4

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8915-12023-02-07C16284748780-1f386c649-faaa-0266-e053-dadaa90a7c1aDrug Facts - Red Cross Canker Sore
10742-8915-12023-01-30C16284748780-1f386c649-faaa-0266-e053-dadaa90a7c1aDrug Facts - Red Cross Canker Sore

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8915-1Red Cross Canker Sore7 g in 1 TUBEOINTMENT74
10742-8915-1Red Cross Canker Sore1 in 1 BLISTER PACKOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8915RED CROSS CANKER SORE (BENZOCAINE) OINTMENT [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 2 package rows20241219_54cfff96-6665-4b36-a15d-10bf6cf3a1f9.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-891510742-8915-1

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

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
Red Cross Canker SoreBENZOCAINEThe Mentholatum Company54cfff96-6665-4b36-a15d-10bf6cf3a1f92024-12-17WarningsExact identifier
ndc (package): 10742-8915-1
ndc (product): 10742-8915
ndc11 (package): 10742891501
spl id: 2979ed4e-4ce2-bd7d-e063-6294a90acb9f
spl set id: 54cfff96-6665-4b36-a15d-10bf6cf3a1f9

Reported adverse events (FAERS/openFDA)#

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