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.

Aids in the prevention of dental cavities.

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

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

Fluoride toothpaste

Children under 6 years of age:
Consult dentist or doctor

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.

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

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.

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

Front FaceBack panel

CURAPROX BLACK IS WHITE 
toothpaste, sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71112-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.095 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM THIOCYANATE (UNII: TM7213864A)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71112-001-201 in 1 BOX03/01/2021
190 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/01/2021
Labeler - Curaden AG (481145555)
Registrant - Curaden AG (481145555)
Establishment
NameAddressID/FEIBusiness Operations
Trybol AG480305077manufacture(71112-001)

Revised: 7/2022
Document Id: e3a32d62-4749-04f0-e053-2a95a90ab1ac
Set id: bf948da3-dc9c-596e-e053-2a95a90aa413
Version: 3
Effective Time: 20220712
 
Curaden AG