FDA.reportPublic FDA data

WHITENING

Manufacturer
Selahatin AB | MEDENA AG
Effective date
2021-07-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:40:00

Label at a glance#

ProductWHITENING ALL VARIANTS
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

Aids in the prevention of dental caries (decay)

Dosage and administration

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

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium Flouride........1100ppm

PURPOSE

OTC - PURPOSE SECTION

Anti-caries

USES

INDICATIONS & USAGE SECTION

  • Aids in the prevention of dental caries (decay)

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ESCAPIST: Aqua/[Water], Sorbitol, Hydrated Silica, CI 77891/[Titanium Dioxide], Sodium Lauryl Sulfate, Aroma/[Flavor], Betaine, Sodium Bicarbonate, Cellulose Gum, Peg-12, Dicalcium Phosphate Dihydrate, Glycerin, Sodium Saccharin, Limonene, Hydroxyapatite, Synthetic Fluorphlogopite, Methylparaben, Potassium Chloride, Cinnamal, Eugenol, Leontopodium Alpinum Extract, Tin Oxide

AMORIST: Aqua/[Water], Sorbitol, Hydrated Silica, CI 77891/[Titanium Dioxide], Sodium Lauryl Sulfate, Betaine, Sodium Bicarbonate, Cellulose Gum, Aroma/[Flavor], Peg-12, Dicalcium Phosphate Dihydrate, Glycerin, Sodium Saccharin, Hydroxyapatite, Limonene, Synthetic Fluorphlogopite, Methylparaben, Potassium Chloride, Menthol, Leontopodium Alpinum Extract, Tin Oxide

HYPNOTIST: Aqua/[Water], Sorbitol, Hydrated Silica, CI 77891/[Titanium Dioxide], Sodium Lauryl Sulfate, Betaine, Sodium Bicarbonate, Cellulose Gum, Aroma/[Flavor], Peg-12, Dicalcium Phosphate Dihydrate, Glycerin, Sodium Saccharin, Hydroxyapatite, Benzyl Alcohol, Synthetic Fluorphlogopite, Methylparaben, Potassium Chloride, Limonene, Leontopodium Alpinum Extract, Tin Oxide

VESPER: Aqua/[Water], Sorbitol, Hydrated Silica, CI 77891/[Titanium Dioxide], Aroma/[Flavor], Sodium Lauryl Sulfate, Betaine, Sodium Bicarbonate, Cellulose Gum, Peg-12, Dicalcium Phosphate Dihydrate, Citric Acid, Glycerin, Sodium Saccharin, Hydroxyapatite, Synthetic Fluorphlogopite, Methylparaben, Limonene, Potassium Chloride, Leontopodium Alpinum Extract, Tin Oxide

BLUE FOREVER: Aqua/[Water], Sorbitol, Hydrated Silica, CI 77891/[Titanium Dioxide], Sodium Lauryl Sulfate, Betaine, Sodium Bicarbonate, Cellulose Gum, Peg-12, Limonene, Dicalcium Phosphate Dihydrate, Aroma/[Flavor], Citric Acid, Glycerin, Sodium Saccharin, Citrus Limon Peel Oil/[Citrus Limon (Lemon) Peel Oil], Hydroxyapatite, Synthetic Fluorphlogopite, Methylparaben, Citrus Aurantifolia Oil/[Citrus Aurantifolia (Lime) Oil], Citral, Potassium Chloride, Leontopodium Alpinum Extract, Tin Oxide

EUKALYPSE: Aqua/[Water], Sorbitol, Hydrated Silica, CI 77891/[Titanium Dioxide], Sodium Lauryl Sulfate, Betaine, Sodium Bicarbonate, Cellulose Gum, Peg-12, Aroma/[Flavor], Dicalcium Phosphate Dihydrate, Eucalyptus Globulus Leaf Oil, Citric Acid, Glycerin, Sodium Saccharin, Benzyl Alcohol, Hydroxyapatite, Menthol, Synthetic Fluorphlogopite, Methylparaben, Limonene, Potassium Chloride, Leontopodium Alpinum Extract, Tin Oxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0-UC (PDP)_Amorist_OuterPackaging_Artwork_1103200-UC (PDP)_Amorist_OuterPackaging_Artwork_110320

0-UC (drug facts box)_FDA-Regulatory-Label-Stickers0-UC (drug facts box)_FDA-Regulatory-Label-Stickers

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80130-10180130-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BETAINE3SCV180C9WIACT
BENZYL ALCOHOLLKG8494WBHIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
LIME OIL, COLD PRESSEDUZH29XGA8GIACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
HYDRATED SILICAY6O7T4G8P9IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 150 MPA.S AT 1%)99H65D77XYIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
POTASSIUM CHLORIDE660YQ98I10IACT
EUGENOL3T8H1794QWIACT
LEONTOPODIUM ALPINUM7R4LQP52DMIACT
CINNAMALDEHYDESR60A3XG0FIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM BICARBONATE8MDF5V39QOIACT
GLYCERINPDC6A3C0OXIACT
STANNIC OXIDEKM7N50LOS6IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
LIMONENE, (+)-GFD7C86Q1WIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
MENTHOL, (+)-C6B1OE8P3WIACT

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
e792eb05-2518-5ac1-e053-2995a90a099ec5a10841-10ff-4eb8-e053-2995a90afe7c2022-08-31WarningsExact identifier
spl set id: c5a10841-10ff-4eb8-e053-2995a90afe7c

Reported adverse events (FAERS/openFDA)#

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