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
FDA Label NDC 71112-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Curaden Ag for the product Curaprox Black Is White (NDC 71112-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding boxed warning, dosage forms & strengths, health claim, inactive ingredient, otc - active ingredient, otc - ask doctor, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage Forms & Strengths
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
Aids in the prevention of dental cavities.
Inactive Ingredient
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
Sodium monofluorophosphate 0.723%
(0.095% W/V fluoride ion)
Fluoride toothpaste
Otc - Ask Doctor
Children under 6 years of age:
Consult dentist or doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Overdosage
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
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
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.
Aids in the prevention of cavities.
* Please review the disclaimer below.
