SELAHATIN - WHITENING TOOTHPASTE - ALL VARIANTS (80130-101) - DELIST

WHITENING by

Drug Labeling and Warnings

WHITENING by is a Otc medication manufactured, distributed, or labeled by Selahatin AB, MEDENA AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WHITENING ALL VARIANTS- sodium fluoride paste, dentifrice 
Selahatin AB

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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SELAHATIN - WHITENING TOOTHPASTE - ALL VARIANTS (80130-101) - DELIST

ACTIVE INGREDIENT

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

PURPOSE

Anti-caries

USES

• Aids in the prevention of dental caries (decay)

WARNINGS

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

Keep out of reach of children.

DIRECTIONS

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

OTHER INFORMATION

• Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS

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

WHITENING  ALL VARIANTS
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80130-101
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BETAINE (UNII: 3SCV180C9W)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 150 MPA.S AT 1%) (UNII: 99H65D77XY)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
EUGENOL (UNII: 3T8H1794QW)
LEONTOPODIUM ALPINUM (UNII: 7R4LQP52DM)
CINNAMALDEHYDE (UNII: SR60A3XG0F)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
STANNIC OXIDE (UNII: KM7N50LOS6)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MENTHOL, (+)- (UNII: C6B1OE8P3W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80130-101-11	1 in 1 BOX	06/25/2021	06/25/2021
1		65 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/25/2021	06/25/2021

Labeler - Selahatin AB (353054206)

Revised: 8/2022

Document Id: e792eb05-2518-5ac1-e053-2995a90a099e

34390-5

Set id: c5a10841-10ff-4eb8-e053-2995a90afe7c

Version: 4

Effective Time: 20220831

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