FDA.reportPublic FDA data

TM-C7 Oral Care

Manufacturer
Pharmacal-International Co., Ltd | Ecoworld Co., Ltd
Effective date
2023-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:38:24

Label at a glance#

ProductTM-C7 Oral Care
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

Aids in prevention of dental cavities. Use twice a day after brushing, meals, and before social occasions.

Dosage and administration

Rinse mouth with this TM-C7 Oral Care about 10~15ml for 30 seconds then expel

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.02%

Purpose

OTC - PURPOSE SECTION

Anticavity mouthwash

Warings

WARNINGS SECTION

Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Uses

INDICATIONS & USAGE SECTION

Aids in prevention of dental cavities. Use twice a day after brushing, meals, and before social occasions.

Directions

DOSAGE & ADMINISTRATION SECTION

Rinse mouth with this TM-C7 Oral Care about 10~15ml for 30 seconds then expel

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water,Glycerin,Allantoin,Acetic acid,Xylitol,Sodium acetate,Sodium Benzoate,GreenTea Extract,Malic acid,L-Menthol,Propolis Extract, fragrance, Sodium Saccharin,Lemon Oil,Cacao Color,Olive Leaf Extract,Sodium carbonate,Stevia

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 7 years or younger must have parent supervision.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24765-131-012023-02-02C16284748780-1f386c649-d470-0266-e053-dadaa90a7c1a8a97ad03-b3eb-4be0-9c8c-42d77a330184
24765-131-012023-01-30C16284748780-1f386c649-d470-0266-e053-dadaa90a7c1a8a97ad03-b3eb-4be0-9c8c-42d77a330184

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24765-13124765-131-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
ACETIC ACIDQ40Q9N063PIACT
XYLITOLVCQ006KQ1EIACT
SODIUM ACETATE4550K0SC9BIACT
SODIUM BENZOATEOJ245FE5EUIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MALIC ACID817L1N4CKPIACT
LEVOMENTHOLBZ1R15MTK7IACT
PROPOLIS WAX6Y8XYV2NOFIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
LEMON OILI9GRO824LLIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
SODIUM CARBONATE45P3261C7TIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
021e481f-bcf2-811e-e063-6294a90a3a9b8a97ad03-b3eb-4be0-9c8c-42d77a3301842023-08-04WarningsExact identifier
spl set id: 8a97ad03-b3eb-4be0-9c8c-42d77a330184

Reported adverse events (FAERS/openFDA)#

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