NDC 40057-1011 Charm Tex

Sodium Monofluorophosphate

NDC Product Code 40057-1011

NDC Product Information

Charm Tex with NDC 40057-1011 is a a human over the counter drug product labeled by Charm-tex, Inc. Usa.. The generic name of Charm Tex is sodium monofluorophosphate. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Charm-tex, Inc. Usa.

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.

Charm Tex 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 MONOFLUOROPHOSPHATE .76 g/100g

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)
  • SORBITOL (UNII: 506T60A25R)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
  • PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Charm-tex, Inc. Usa.
Labeler Code: 40057
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: 06-15-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Charm Tex Product Label Images

Charm Tex 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 monofluorophosphate - 0.76% (0.1% w/v fluoride ion)

Purpose

Anticavity.

Use

Helps protect against cavities.

Warnings

Keep out of the reach of children under 6 years of age. If more than used for brushing, is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Adults And Children 6 Years Of Age And Older:

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

Children 2 To 6 Years:

Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

Children Under 2 Years:

Ask a dentist or physician.

Inactive Ingredients

Purified Water, Sorbitol, Calcium Carbonate, Flavor, Sodium Lauryl Sulphate, Sodium Saccharin, Silica, Sodium Carboxy Methyl Cellulose, Sodium Methyl Paraben, Sodium Propyl Paraben, Titanium Dioxide, Xanthan Gum.

Keep Out Of Reach Of Children Under 6 Years Of Age

Keep out of reach of children under 6 years of ageProduct of IndiaExclusive Distributor:
Charm-Tex, Inc. USA.
1618, Coney Island, Brooklyn,
New York City 11230.Expires: 2 years from the Date of Mfg.
E.C. No: GUJ/COS/GC/32/1374.Mfg.Date & Batch No. on Crimp.
May 2019

* Please review the disclaimer below.

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