FDA.reportPublic FDA data

Curaprox Black Is White

Manufacturer
Curaden AG | Trybol AG
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:47:14

Label at a glance#

ProductCuraprox Black Is White
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure12 sections

Boxed warning

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.

Label contents#

Full prescribing information#

BOXED WARNING 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.

WarningWarning

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.

Children under 6 years of age:
Instruct in good brushing and rising habits (to minimize swallowing). Supervise children as necessary until capanble of using without supervision. Consult dentist or doctor.

DosageDosage

INACTIVE INGREDIENT SECTION

AQUA, SORBITOL, HYDRATED SILICA, GLYCERIN, CHARCOAL POWDER, AROMA, DECYL GLUCOSIDE, COCAMIDOPROPYL BETAINE, TOCOPHEROL, XANTHAN GUM, MALTODEXTRIN, MICA, HYDROXYAPATITE (NANO), POTASSIUM ACESULFAME, TITANIUM DIOXIDE, MICROCRYSTALLINE CELLULOSE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, CITRUS LIMON PEEL OIL, SODIUM HYDROXIDE, ZEA MAYS STARCH, AMYLOGLUCOSIDASE, GLUCOSE OXIDASE, URTICA DIOICA LEAF EXTRACT, POTASSIUM THIOCYANATE, CETEARYL ALCOHOL, HYDROGENATED LECITHIN, MENTHYL LACTATE, METHYL DIISOPROPYL PROPIONAMIDE, ETHYL MENTHANE CARBOXAMIDE, STEARIC ACID, MANNITOL, SODIUM BISULFITE, TIN OXIDE, LACTOPEROXIDASE, LIMONENE

Inactive ingredientsInactive ingredients

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

IndicationIndication

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.723%
0.095% w/v fluoride ion

Active ingredientActive ingredient

OTC - ASK DOCTOR SECTION

Children under 6 years of age:
Consult dentist or doctor

Ask doctorAsk doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Keep from childrenKeep from children

OTC - PURPOSE SECTION

Aids in the prevention of dental cavities.

PurposePurpose

OTC - WHEN USING SECTION

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

When usinigWhen usinig

OTHER SAFETY INFORMATION

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

OtherOther

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.

WarningsWarnings

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See artwork

ArtworkArtwork

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71112-001-212024-01-30C16284748780-11030e365-6a02-111a-e063-dadaa90a10e2ee03ecde-2251-cf35-e053-2a95a90a42fc

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71112-00171112-001-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
POTASSIUM THIOCYANATETM7213864AIACT
WATER059QF0KO0RIACT

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
ee03ecde-2252-cf35-e053-2a95a90a42fcee03ecde-2251-cf35-e053-2a95a90a42fc2022-11-21Boxed warning, WarningsExact identifier
spl id: ee03ecde-2252-cf35-e053-2a95a90a42fc
spl set id: ee03ecde-2251-cf35-e053-2a95a90a42fc

Reported adverse events (FAERS/openFDA)#

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