Curaprox Black Is White by Curaden AG / Trybol AG

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]

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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.

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

Aids in the prevention of dental cavities.

Sodium monofluorophosphate 0.723%
0.095% w/v fluoride ion

Children under 6 years of age:
Consult dentist or doctor

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

Aids in the prevention of dental cavities.

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.

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

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.

See artwork

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)	Â
WATER (UNII: 059QF0KO0R)	Â

Product Characteristics
Color	   Â	Score	   Â
Shape		Size
Flavor	MINT	Imprint Code
Contains	   Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71112-001-21	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 - Trybol AG (480305077)

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

Revised: 11/2022

Document Id: ee03ecde-2252-cf35-e053-2a95a90a42fc

34390-5

Set id: ee03ecde-2251-cf35-e053-2a95a90a42fc

Version: 1

Effective Time: 20221121

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