NDC 75065-002 Mouthwash For Gum Health

Sodium Fluoride

NDC Product Code 75065-002

NDC 75065-002-01

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Mouthwash For Gum Health with NDC 75065-002 is a a human over the counter drug product labeled by Oral Spotlight Care Inc. The generic name of Mouthwash For Gum Health is sodium fluoride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Oral Spotlight Care Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Mouthwash For Gum Health 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.

  • SODIUM FLUORIDE .2 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SORBITOL (UNII: 506T60A25R)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • PSEUDOMONAS GLUCOSE FERMENTATION RHAMNOLIPIDS (UNII: PB22NX2CJL)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SAFFLOWER (UNII: 4VBL71TY4Y)
  • ALLANTOIN (UNII: 344S277G0Z)
  • BETA VULGARIS (UNII: 4G174V5051)
  • SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Oral Spotlight Care Inc
Labeler Code: 75065
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: 05-01-2021 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".

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Mouthwash For Gum Health Product Label Images

Mouthwash For Gum Health 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

Other

Drug Facts

Otc - Active Ingredient

Sodium Fluoride 0.05% (.02% w/v fluoride ion)

Otc - Purpose

Purpose  Anticavity

Indications & Usage

Use  aids in the prevention of dental cavities.

Warnings

Warnings

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If more than used is accidentally swallowed, getmedical help or contact a Poison Control Center right away.

Dosage & Administration

Directions• Adults and children 6 years of age and older:• Use once a day after brushing your teeth with a toothpaste.• Vigorously swish 10 milliliters (2 teaspoonfuls) of rinse between yourteeth for 1 minute and then spit out.• Do not swallow the rinse.• Do not eat or drink for 30 minutes after rinsing.• Instruct children under 12 years of age in good rinsinghabits (to minimize swallowing).• Supervise children as necessary until capable of usingwithout supervision• Children under 6 years of age: Consult a dentist or doctor

Other Safety Information

Other information • Store at room temperature.

Inactive Ingredient

Inactive ingredientsDeionized Waler, Glycerin, Xylital, Sorbitol, Poloxamer 407,Glycolipid, Mentha Arvensis (peppemint) Oil, Xanthan Gum,Potassium Sorbate, Carrageenan, Sodium Benzoate, SodiumSaccharin, Carthamus Tinctorius, Allantoin, Beta Vulgaris,Spirulina Maxima

Otc - Questions

Questions?  +1 (646) 9806461

Product Label

Spotlight® Oral CareCREATED BY DENTISTS       GMouthwashfor Gum HealthAids in Relieving Symptomsof Bad Breath, Inflamed& Bleeding Gums-- Active Ingredient --  Sodium Fluoride--- Alcohol Free --Anticavity Fuoride MouthwashPeppermint FlavorIMPORTANT: Read directions for proper use.NET WT.  16.9 fl oz (500mL)MADE IN THE USASpotlight Oral Care, 90 South Dale, Suite #8,Saint Paul, Minnesota, USA 55102res

* Please review the disclaimer below.