FDA.reportPublic FDA data

BLACK IS WHITE

Manufacturer
CURADEN AG
Effective date
2019-04-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:26:26

Label at a glance#

ProductBLACK IS WHITE
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Indications and uses

AIDS IN THE PREVENTION OF DENTAL CARIES (DECAY)

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

SODIUM MONOFLUOROPHOSPHATE...950 PPM

PURPOSES

OTC - PURPOSE SECTION

ANTI-CARIES

USES

INDICATIONS & USAGE SECTION

AIDS IN THE PREVENTION OF DENTAL CARIES (DECAY)

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. 

WARNINGS SECTION

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

OTHER SAFETY INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

INFO@CURADEN.CH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01_73314548_Einlage_set_VP_BlackIsWhite_USA_43x228_0417_screen_Page_101_73314548_Einlage_set_VP_BlackIsWhite_USA_43x228_0417_screen_Page_1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71112-10271112-102-13, 71112-102-53

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
LIPROTAMASE AMYLASEI909J9CFATIACT
BENTONITEA3N5ZCN45CIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
SODIUM COPPER CHLOROPHYLLIN1D276TYV9OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LEMON OILI9GRO824LLIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ETHYL MENTHANE CARBOXAMIDE6S7S02945HIACT
METHYL SALICYLATELAV5U5022YIACT
GLUCOSE OXIDASE0T8392U5N1IACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
MYELOPEROXIDASEJQZ6YM58U5IACT
LIMONENE, (+)-GFD7C86Q1WIACT
MALTODEXTRIN7CVR7L4A2DIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
POTASSIUM CHLORIDE660YQ98I10IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POTASSIUM THIOCYANATETM7213864AIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
STANNIC OXIDEKM7N50LOS6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
STARCH, CORNO8232NY3SJIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9feba2a4-d292-4217-bb62-683cefa7eb169c9d6021-12fa-45bf-9e40-e4d7c1c77f402020-05-31WarningsExact identifier
spl set id: 9c9d6021-12fa-45bf-9e40-e4d7c1c77f40

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.