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.
Curaprox Black Is White
- Manufacturer
- Curaden AG | Trybol AG
- Effective date
- 2022-07-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:50:08
Label at a glance#
ProductCuraprox Black Is White
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure14 sections
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.
DOSAGE FORMS & STRENGTHS 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.
HEALTH CLAIM SECTION
Aids in the prevention of dental cavities.
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, LIMON
OTC - ACTIVE INGREDIENT SECTION
Sodium monofluorophosphate 0.723%
(0.095% W/V fluoride ion)
Fluoride toothpaste
OTC - ASK DOCTOR SECTION
Children under 6 years of age:
Consult dentist or doctor
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children under 6 years of age.
OVERDOSAGE SECTION
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION
Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by 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
Apply small bead on bristles of toothbrush. Use bristles with toothpaste to brush all around teeth to include gum line.
Use
Aid in the prevention of dental cavities.
Use
Aids in the prevention of cavities.
Outer package artwork
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71112-001-20 | 2024-01-30 | C162847 | 48780-1 | 1030e365-106a-111a-e063-dadaa90a10e2 | bf948da3-dc9c-596e-e053-2a95a90aa413 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71112-001-20 | Curaprox Black Is White | 90 mL in 1 TUBE | PASTE, DENTIFRICE | 90 | 3 | |
| 71112-001-20 | Curaprox Black Is White | 1 in 1 BOX | PASTE, DENTIFRICE | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Curaprox Black Is White
- Toothpaste, Sodium Monofluorophosphate
- SODIUM MONOFLUOROPHOSPHATE
- FLUORIDE ION
- POTASSIUM THIOCYANATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71112-001 | 71112-001-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM MONOFLUOROPHOSPHATE | C810JCZ56Q | ACTIM |
| POTASSIUM THIOCYANATE | TM7213864A | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e3a32d62-4749-04f0-e053-2a95a90ab1ac | bf948da3-dc9c-596e-e053-2a95a90aa413 | 2022-07-12 | Boxed warning, Warnings | e3a32d62-4749-04f0-e053-2a95a90ab1ac bf948da3-dc9c-596e-e053-2a95a90aa413 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.