FDA.reportPublic FDA data

Canker Care Plus

Manufacturer
Quantum, Inc. | Sun Deep Inc.
Effective date
2025-10-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:39:49

Label at a glance#

ProductCanker Care Plus
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

For the temporary relief of mouth pain associated with canker sores, toothache, dentures, braces or cheek bites.

Dosage and administration

Apply to affected area up to 4 times a day, or as directed by a doctor or dentist.

Storage and handling

Do not use if shrink wrap seal covering bottle and cap is broken or missing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.5%

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of mouth pain associated with canker sores, toothache, dentures, braces or cheek bites.

Warnings

WARNINGS SECTION

Do not use this product for more than 7 days unless directed by a health professional. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness worsens; or if swelling, rash or fever develops; see your doctor or dentist. Do not exceed recommended dosage. Avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected area up to 4 times a day, or as directed by a doctor or dentist.

Other Information

STORAGE AND HANDLING SECTION

Do not use if shrink wrap seal covering bottle and cap is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice (Aloe Vera Gel), Calendula Officinalis Extract, Cellulose Gum, Commiphora Myrrha (Myrrh) Extract, Cyanocobalamin (Vitamin B12), Dipotassium Glyrrhizinate (DGL, Licorice), Echinacea Purpurea Extract, Eugenia Ceryophyllus (Clove Bud) Oil, Glycerine, Hydrastis Canadensis (Goldenseal) Leaf, Lysine, Melaleuca Alternifolia (Tea Tree) Oil, Melaleuca Leucadendron (Cajuputi) Oil, Mentha Piperita (Peppermint) Oil, Castor Oil, Polysorbate 20, Propolis Extract,Purified Water, Zinc

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: QUANTUM, INC.
PO BOX 2791, EUGENE, OR 97402

PRINCIPAL DISPLAY PANEL - 9.4 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quantum ®
HEALTH

Canker Care + ®

Oral Gel
Pain Reliever
IMMEDIATE PAIN RELIEF

SOOTHING PROTECTIVE GEL
FRESH NATURAL TASTE

WITH 15NUTRIENTS INCLUDING LYSINE, LICORICE,
ALOE VERA, PROPOLIS AND TEA TREE OIL.

GENTLE BRUSH APPLICATOR

.33 FL OZ / 9.4 mL

PRINCIPAL DISPLAY PANEL - 9.4 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 9.4 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1812752Canker Care 0.5 % Topical SolutionPSN4
1812747menthol 0.5 % Topical SolutionPSN4
1812752menthol 5 MG/ML Topical Solution [Canker Care]SBD4
1812747menthol 5 MG/ML Topical SolutionSCD4
1812752Canker Care 5 MG/ML Topical SolutionSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130046985017862GTIN-13: 0046985017862
EAN-13: 0046985017862
GTIN-12: 046985017862
UPC-A: 046985017862
GTIN storage (14 digits): 00046985017862		cankercare-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70084-500-012025-01-30C16284748780-1ba0f9c33-1ad8-a910-e053-dadaa90a0b85Canker Care + ®
70084-500-012025-01-30C16284748780-1ba0f9c33-1ad8-a910-e053-dadaa90a0b85Canker Care + ®
70084-500-012023-02-09C16284748780-1ba0f9c33-1ad8-a910-e053-dadaa90a0b85Canker Care + ®
70084-500-012023-02-09C16284748780-1ba0f9c33-1ad8-a910-e053-dadaa90a0b85Canker Care + ®
70084-500-012021-01-29C16284748780-1ba0f9c33-1ad8-a910-e053-dadaa90a0b85Canker Care + ®
70084-500-012021-01-29C16284748780-1ba0f9c33-1ad8-a910-e053-dadaa90a0b85Canker Care + ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70084-500-01Canker Care Plus9.7 mL in 1 BOTTLELIQUID9.74
70084-500-01Canker Care Plus1 in 1 CARTONLIQUID14

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70084-50070084-500-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA PURPUREA WHOLEQI7G114Y98IACT
TEA TREE OILVIF565UC2GIACT
MELALEUCA CAJUPUTI LEAF OIL5O59RMR6DUIACT
GOLDENSEALZW3Z11D0JVIACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
PROPOLIS WAX6Y8XYV2NOFIACT
WATER059QF0KO0RIACT
CASTOR OILD5340Y2I9GIACT
CYANOCOBALAMINP6YC3EG204IACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
MYRRHJC71GJ1F3LIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
CLOVE OIL578389D6D0IACT
GLYCERINPDC6A3C0OXIACT
LICORICE61ZBX54883IACT
PEPPERMINT OILAV092KU4JHIACT
POLYSORBATE 207T1F30V5YHIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32023-02-06full-release2026-05-31 23:53:48

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
Canker Care PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.1ec960db-52d5-4d99-a7f7-a2e538d287242025-10-20WarningsExact identifier
ndc (package): 70084-500-01
ndc (product): 70084-500
ndc11 (package): 70084050001
spl id: 419ce34e-1e05-d86c-e063-6294a90aade0
spl set id: 1ec960db-52d5-4d99-a7f7-a2e538d28724

Reported adverse events (FAERS/openFDA)#

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