NDC 44717-890 Canker Complete Canker Sore Relief

NDC Product Code 44717-890

NDC 44717-890-02

Package Description: 1 TUBE in 1 BOX > 6 g in 1 TUBE (44717-890-01)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Canker Complete Canker Sore Relief with NDC 44717-890 is a product labeled by Wasatch Product Development. The generic name of Canker Complete Canker Sore Relief is . The product's dosage form is and is administered via form.

Labeler Name: Wasatch Product Development

Dosage Form: -

Product Type: 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.

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.

  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • CHLORELLA VULGARIS (UNII: RYQ4R60M02)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • CERAMIDE 2 (UNII: C04977SRJ5)
  • PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Labeler Information

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

Labeler Name: Wasatch Product Development
Labeler Code: 44717
Start Marketing Date: 10-12-2010 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: 12-31-2019 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: I 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.

Canker Complete Canker Sore Relief Product Label Images

Canker Complete Canker Sore Relief 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

Otc - Active Ingredient

Active ingredient                              Purpose  Menthol 0.5%                                  Oral Pain Reliever

Otc - Purpose

Uses        For the temporary relief of pain associated with canker and mouth sores

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children

Indications & Usage

Stop use and ask a dentist or physician if- Sore mouth symptoms do not improve in 7 days- Irritation, pain or redness worsens- Swelling, rash or fever develops

Warnings

Do not use this product for more than 7 days unless directed by a health professional

Dosage & Administration

DirectionsAdults and children 2 years and older              Gently dab medication on the site of irritation with a cotton swab or fingertip                                                                   Apply to the affected area up to 4 times a day, or as directed by a dentist or physicianChildren under 12 years                               Adult supervision should be given in the use of this productChildren under 2 years                                 Consult dentist or physician

Inactive Ingredient

Inactive ingredients:Calcium/Sodium PVM/MA Copolymer, TX-Factor 5 tm (propietary polypeptide lipid blend), Cellulose Gum, Mineral Oil,  Petrolatum, Lecithin, Chlorella Vulgaris  Extract, Hydrolyzed Lupine Protein, Silica, C12-15 Alkyl  Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Tetrasodium EDTA, Flavor, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Caprylyl Glycol, Stearyl Glycyrrhetinate, Sucralose, DC Red Lake 27

* Please review the disclaimer below.