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.

Warning

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.

Dosage

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

Inactive ingredients

Aids in the prevention of dental cavities.

Indication

Sodium monofluorophosphate 0.723%
0.095% w/v fluoride ion

Active ingredient

Children under 6 years of age:
Consult dentist or doctor

Ask doctor

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

Keep from children

Aids in the prevention of dental cavities.

Purpose

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.

When usinig

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

Other

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.

Warnings

See artwork

Artwork

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)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71112-001-211 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 - Trybol AG (480305077)
Establishment
NameAddressID/FEIBusiness Operations
Trybol AG480305077manufacture(71112-001)

Revised: 11/2022
Document Id: ee03ecde-2252-cf35-e053-2a95a90a42fc
Set id: ee03ecde-2251-cf35-e053-2a95a90a42fc
Version: 1
Effective Time: 20221121
 
Curaden AG