FDA.reportPublic FDA data

CAREKON ANTI-CAVITY FLUORIDE

Manufacturer
Hunan Yinhuatang Pharmaceutical Technology Co., Ltd.
Effective date
2025-08-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:12:03

Label at a glance#

ProductCAREKON ANTI-CAVITY FLUORIDE
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.76g/100g)

OTC - PURPOSE SECTION

Anticavity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

INDICATIONS & USAGE SECTION

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

WARNINGS SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, Dicalcium Phosphate, Hydroxyapatite, Glycerin, Cocamidopropyl Betaine, Sodium Lauroyl Sarcosinate, Fragrance, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Saccharin, Citric Acid, Beta-Glucan

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

yht1yht1yht2yht2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84345-086-01CAREKON ANTI-CAVITY FLUORIDE100 g in 1 TUBEPASTE1002
84345-086-01CAREKON ANTI-CAVITY FLUORIDE1 in 1 BOXPASTE12

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84345-08684345-086-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRASODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
FRAGRANCE 135765EM498GW35IACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYDROXYAPATITE91D9GV0Z28IACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
1,3-BETA-GLUCAN SYNTHASE COMPONENT FKS14FRY3LJG0VIACT
CELLULOSE GUMK679OBS311IACT
WATER059QF0KO0RIACT
DICALCIUM PHOSPHATEL11K75P92JIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SODIUM SACCHARINSB8ZUX40TYIACT

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
CAREKON ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEHunan Yinhuatang Pharmaceutical Technology Co., Ltd.3baca3b6-ff48-0579-e063-6394a90abd082025-08-29WarningsExact identifier
ndc (package): 84345-086-01
ndc (product): 84345-086
ndc11 (package): 84345008601
spl id: 3d7df7bc-ffb3-b222-e063-6294a90a5024
spl set id: 3baca3b6-ff48-0579-e063-6394a90abd08

Reported adverse events (FAERS/openFDA)#

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