CURAPROX BLACK IS WHITE- toothpaste, sodium monofluorophosphate paste, dentifrice

Curaprox Black Is White by

Drug Labeling and Warnings

Curaprox Black Is White by is a Otc medication manufactured, distributed, or labeled by Curaden AG, Trybol AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

(What is this?)

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

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

ACTIVE INGREDIENT

Sodium monofluorophosphate 0.723%
(0.095% W/V fluoride ion)

Fluoride toothpaste

ASK DOCTOR

Children under 6 years of age:
Consult dentist or doctor

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.

Use

Aids in the prevention of cavities.

Outer package artwork

INGREDIENTS AND APPEARANCE

CURAPROX BLACK IS WHITE 
toothpaste, sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71112-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.095 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM THIOCYANATE (UNII: TM7213864A)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71112-001-20	1 in 1 BOX	03/01/2021
1		90 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/01/2021

Labeler - Curaden AG (481145555)

Registrant - Curaden AG (481145555)

Establishment
Name	Address	ID/FEI	Business Operations
Trybol AG		480305077	manufacture(71112-001)