WHITE IS BLACK by CURADEN AG / CURADEN PRODUCTION AG

WHITE IS BLACK by

Drug Labeling and Warnings

WHITE IS BLACK by is a Otc medication manufactured, distributed, or labeled by CURADEN AG, CURADEN PRODUCTION AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WHITE IS BLACK- sodium monofluorophosphate gel, dentifrice 
CURADEN AG

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENTS

SODIUM MONOFLUOROPHOSPHATE...950 PPM

PURPOSES

ANTI-CARIES

USES

AIDS IN THE PREVENTION OF DENTAL CARIES (DECAY)

DIRECTIONS

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY, PREFERABLY AFTER EACH MEAL OR ATLEAST TWICE A DAY, OR AS DIRECTED BY A DENTIST OR DOCTOR. INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. 

CHILDREN UNDER 2 YEARS OF AGE: CONSULT A DENTIST OR DOCTOR.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. 

WARNINGS: IF MORE THAN THE AMOUNT USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. 

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

Water (Aqua), Sorbitol, Hydrated Silica, Glycerin, Charcoal Powder, Aroma (Flavor), Bentonite, Decyl Glucoside, Cocamidopropyl Betaine, Tocopherol, Xanthan Gum, Mica, Hydroxyapatite, Potassium Acesulfame, Maltodextrin, Sodium Benzoate, Microcrystalline Cellulose, Potassium Sorbate, Potassium Chloride, Citrus Limon Peel Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Citric Acid, Lactoperoxidase, Glucose Oxidase, Amyloglucosidase, Potassium Thiocyanate, Sucrose, Zea Mays Starch, Stearic Acid, Cetearyl Alcohol, Tin Oxide, Hydrogenated Lecithin, Limonene, Titanium Dioxide (CI 77891), Chlorophyllin-Copper Complex (CI 75815)

QUESTIONS?

INFO@CURADEN.CH

WHITE IS BLACK 
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71112-101
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.095 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
LIPROTAMASE AMYLASE (UNII: I909J9CFAT)
BENTONITE (UNII: A3N5ZCN45C)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LEMON OIL (UNII: I9GRO824LL)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
METHYL SALICYLATE (UNII: LAV5U5022Y)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
MYELOPEROXIDASE (UNII: JQZ6YM58U5)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM THIOCYANATE (UNII: TM7213864A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	black	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71112-101-53	1 in 1 BOX	01/29/2017	01/13/2020
1	NDC: 71112-101-13	90 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/29/2017	01/13/2020

Labeler - CURADEN AG (480027255)

Establishment
Name	Address	ID/FEI	Business Operations
CURADEN PRODUCTION AG		486745818	manufacture(71112-101)

Revised: 1/2020

Document Id: 5353a712-32d1-4b59-b7e1-d9c553a0e8ba

34390-5

Set id: 5c4051c7-80e9-4af8-a24c-1567e78aea77

Version: 3

Effective Time: 20200113

 

CURADEN AG