FDA.reportPublic FDA data

CURODONT PROTECT

Manufacturer
CREDENTIS AG
Effective date
2024-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:42:12

Label at a glance#

ProductCURODONT PROTECT
Active ingredientSTANNOUS FLUORIDE
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

STANNOUS FLUORIDE 0.454%

(0.14% W/V FLUORIDE ION)

PURPOSE

OTC - PURPOSE SECTION

ANTICAVITY AND ANTISENSITIVITY

USE

INDICATIONS & USAGE SECTION

  • AIDS IN THE PREVENTION OF DENTAL CAVITIES AND BUILDS INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH.

WARNINGS

WARNINGS SECTION

Stop use and ask a doctor if

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

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). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, Sodium Tripolyphosphate, Sodium Gluconate, Xylitol, Cellulose Gum, Oligopeptide-104, Sodium Hydroxide, Phosphoric Acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DFDF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN3
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD3
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY3
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY3
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72247-107-10CURODONT PROTECT0.13 g in 1 TUBEPASTE, DENTIFRICE0.133
72247-107-10CURODONT PROTECT10 in 1 BOXPASTE, DENTIFRICE103
72247-107-13CURODONT PROTECT1 in 1 BOXPASTE, DENTIFRICE13
72247-107-13CURODONT PROTECT0.13 g in 1 TUBEPASTE, DENTIFRICE0.133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72247-107CURODONT PROTECT (STANNOUS FLUORIDE) PASTE, DENTIFRICE [CREDENTIS AG]3Current NDC, 4 package rows20241213_03ec591c-68c3-a380-e063-6394a90a131a.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72247-10772247-107-13, 72247-107-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM TRIPOLYPHOSPHATE5HK03SA80JIACT
SODIUM GLUCONATER6Q3791S76IACT
OLIGOPEPTIDE 104MUM5TLH7X6IACT
XYLITOLVCQ006KQ1EIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
PHOSPHORIC ACIDE4GA8884NNIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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
CURODONT PROTECTSTANNOUS FLUORIDECREDENTIS AG03ec591c-68c3-a380-e063-6394a90a131a2024-12-01WarningsExact identifier
ndc (package): 72247-107-13
ndc (package): 72247-107-10
ndc (product): 72247-107
ndc11 (package): 72247010710
ndc11 (package): 72247010713
spl id: 284225ec-2b67-6ed5-e063-6294a90a89df
spl set id: 03ec591c-68c3-a380-e063-6394a90a131a

Reported adverse events (FAERS/openFDA)#

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