NDC 80130-102 Selahatin All Variants

Sodium Fluoride

NDC Product Code 80130-102

NDC 80130-102-20

Package Description: 200 mL in 1 BOTTLE

NDC Product Information

Selahatin All Variants with NDC 80130-102 is a a human over the counter drug product labeled by Selahatin Ab. The generic name of Selahatin All Variants is sodium fluoride. The product's dosage form is mouthwash and is administered via dental form.

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Selahatin All Variants Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MENTHOL, (+)- (UNII: C6B1OE8P3W)
  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Selahatin Ab
Labeler Code: 80130
FDA Application Number: part355 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-31-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Selahatin All Variants Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 one or more ingredients. Do not use in association with other mouthwash products.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Adults only: spray the undiluted mouthwash into the mouth once or twice a day after the usual teeth cleaning routine. Rinse closed mouth for 30 to 60 seconds, then spit out.

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, BHTELISE: 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

* Please review the disclaimer below.