Label: CURAPROX BLACK IS WHITE- toothpaste, sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 71112-001-21 - Packager: Curaden AG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 21, 2022
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- BOXED WARNING (What is this?)
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DOSAGE & ADMINISTRATION
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.
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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, LIMONENE
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- WHEN USING
- OTHER SAFETY INFORMATION
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CURAPROX BLACK IS WHITE
toothpaste, sodium monofluorophosphate paste, dentifriceProduct 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) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71112-001-21 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)
