NDC 74690-012 Farmasi Whitening

Sodium Fluoride

NDC Product Code 74690-012

NDC 74690-012-01

Package Description: 1 TUBE in 1 BOX > 112 g in 1 TUBE

NDC Product Information

Farmasi Whitening with NDC 74690-012 is a a human over the counter drug product labeled by Farmasi Us Llc. The generic name of Farmasi Whitening is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Farmasi Us Llc

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

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.

Farmasi Whitening 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 1.5 mg/g

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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SALVADORA PERSICA ROOT (UNII: 526M7ZU616)

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: Farmasi Us Llc
Labeler Code: 74690
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: 04-15-2021 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.

Farmasi Whitening Product Label Images

Farmasi Whitening 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 Ingredients

Sodium Fluoride 0.24 %

(0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

Helps proctect teeth and prevents cavities. Whitens teeth by removing surface stains.

Keep Out Of Reach Of Children

Under 6 years of age. If more than used for brushing in accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older: brush teeth thoroughly after meals of at least twice a day, or as directed by a dentist or physician.

Inactive Ingredients

Calcium Carbonate, Sorbitol, Water/Aqua, Hydrated Silica, Lauryl Glucoside, Xanthan Gum, Flavour/Aroma, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tea Tree Oil/Melaleuca Alternifolia Leaf Oil, Panax Ginseng Root Extract, Aloe Juice/Aloe Barbadensis Leaf Juice, Salvadora Persica Bark/Root Extract.

* Please review the disclaimer below.