SELAHATIN - MOUTHWASH - ALL VARIANTS (80130-102) - DELIST

SELAHATIN by

Drug Labeling and Warnings

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

Drug Details [pdf]

SELAHATIN ALL VARIANTS- sodium fluoride mouthwash 
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 - MOUTHWASH - ALL VARIANTS (80130-102) - DELIST

ACTIVE INGREDIENT

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

PURPOSE

Anti-caries

USES

• Aids in the prevention of dental caries (decay)

WARNINGS

Do not rinse mouth with water afterwards. The mouthwash does not replace the regular tooth hygiene routine.

Do not:

• Use in case of a known hypersensitivity or allergy to any of the ingredients.
• Use in association with other mouthwash products.

Keep out of reach of children.

DIRECTIONS

1) Use once or twice a day after brushing your teeth 2) Rinse in closed mouth for 30-60 seconds 3) Spit out. Don’t swallow.

Do not eat or drink for 30 minutes after use.

This mouthwash is not a substitute for your regular dental hygien

OTHER INFORMATION

• Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS

ESCAPIST: Aqua/[Water], Glycerin, Pvp, Polysorbate 20, Propylene Glycol, Poloxamer 407, PEG-40 Hydrogenated Castor Oil, Sodium Citrate, Aroma/[Flavor], Potassium Sorbate, Sodium Benzoate, Sodium Phosphate, Tocopheryl Acetate, Disodium Phosphate, Panthenol, Limonene, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Cetylpyridinium Chloride, Sodium Saccharin, BHT

ELISE: Aqua/[Water], Glycerin, Pvp, Polysorbate 20, Propylene Glycol, Poloxamer 407, PEG-40 Hydrogenated Castor Oil, Sodium Citrate, Potassium Sorbate, Sodium Benzoate, Limonene, Sodium Phosphate, Aroma/[Flavor], Tocopheryl Acetate, Menthyl Ethylamido Oxalate, Disodium Phosphate, Panthenol, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Cetylpyridinium Chloride, Sodium Saccharin, Citrus Limon Peel Oil/[Citrus Limon (Lemon) Peel Oil], Eucalyptus Globulus Leaf Oil, Citrus Aurantifolia Oil/[Citrus Aurantifolia (Lime) Oil], Citral, BHT

SELAHATIN  ALL VARIANTS
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80130-102
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.11 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHYL ETHYLAMIDO OXALATE (UNII: G2MB8B7PSM)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PANTHENOL (UNII: WV9CM0O67Z)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LEMON OIL (UNII: I9GRO824LL)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LIME OIL (UNII: UZH29XGA8G)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80130-102-20	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2021	08/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/31/2021	08/31/2021

Labeler - Selahatin AB (353054206)

Revised: 8/2022

Document Id: e792e252-8d87-dcde-e053-2a95a90a436e

34390-5

Set id: cae0c7a0-8aca-177e-e053-2a95a90a78e7

Version: 8

Effective Time: 20220831

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