NDC 67659-160 Dentemp Canker Sore Single Dose

Dentemp Canker Sore

NDC Product Code 67659-160

NDC CODE: 67659-160

Proprietary Name: Dentemp Canker Sore Single Dose What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dentemp Canker Sore What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
PINK (C48328 - PINK (ONE SIDE PINK, ONE SIDE WHITE))
Shape: ROUND (C48348)
Size(s):
10 MM
Score: 1
Flavor(s):
CITRUS (C73378)

NDC Code Structure

  • 67659 - Team Technologies, Inc

NDC 67659-160-07

Package Description: 6 mg in 1 CARTON

NDC Product Information

Dentemp Canker Sore Single Dose with NDC 67659-160 is a a human over the counter drug product labeled by Team Technologies, Inc. The generic name of Dentemp Canker Sore Single Dose is dentemp canker sore. The product's dosage form is tablet, extended release and is administered via oral; topical form.

Labeler Name: Team Technologies, Inc

Dosage Form: Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.

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.

Dentemp Canker Sore Single Dose 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.

  • MENTHOL 2.5 mg/150mg

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.

  • POVIDONE K90 (UNII: RDH86HJV5Z)
  • ANNATTO (UNII: 6PQP1V1B6O)
  • CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • POVIDONE K30 (UNII: U725QWY32X)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Team Technologies, Inc
Labeler Code: 67659
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-05-2021 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.

Dentemp Canker Sore Single Dose Product Label Images

Dentemp Canker Sore Single Dose 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 (per each tablet)
Menthol 2.5 mg

Indications & Usage

Indications and UsageFor the temporary relief of pain associated with canker sores

Warnings

WarningsDo not use this product for more than 7 days unless directed by a dentist or doctor.Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 daysirritation, pain or redness worsens swelling, rash or fever developsDo not exceed recommended dosage.WARNINGSKeep out of reach of children. In case of accidental overdose, get medical help or contact aPoison Control Center (1-800-222-1222) right away.PREGNANCY OR BREASTFEEDING
If pregnant, or breast-feeding or taking prescription drugs, ask a health care professional - before use

Instructions For Use

Directions .adults and children 5 years of age and older, apply up to 3 tablets per day,
as needed. Place the tablet on a clean, dry finger with the white side up. Place the white side onthe sore and hold in place for 10 seconds. If sore is difficult to reach (in the fold between thecheek and gum or near the teeth or lip) break the tablet along the score and use half. Somediscomfort may occur during the first few minutes, but will quickly subside, followed by hours ofsoothing relief. Within 30 minutes the tablet forms a clear, gel-like bandage that seals andprotects the sore for hours before dissolving. Do not remove the tablet before it dissolves. Incase of discomfort, the tablet may be removed by gently peeling the tablet from the sides whilewashing with warm water. Do not use any instrument to remove the tablet..children under 5 years, ask a doctor

Storage And Handling

Other information store in a cool, dry place.

Inactive Ingredient

Inactive ingredients annato, carbomer homopolymer type a, citrus oil, hydroxypropyl - cellulose, magnesium chloride, povidone K30, povidone K90,silicon dioxide, xylitol

Otc - Questions

Questions or comments? 833-363-2763 or [email protected]

Dosage & Administration

Directions .adults and children 5 years of age and older, apply up to 3 tablets per day,as needed. Place the tablet on a clean, dry finger with the white side up. Place the white side onthe sore and hold in place for 10 seconds. If sore is difficult to reach (in the fold between thecheek and gum or near the teeth or lip) break the tablet along the score and use half. Somediscomfort may occur during the first few minutes, but will quickly subside, followed by hours ofsoothing relief. Within 30 minutes the tablet forms a clear, gel-like bandage that seals andprotects the sore for hours before dissolving. Do not remove the tablet before it dissolves. Incase of discomfort, the tablet may be removed by gently peeling the tablet from the sides whilewashing with warm water. Do not use any instrument to remove the tablet..children under 5 years, ask a doctor

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose,get medical help or contact aPoison Control Center (1-800-222-1222) right away.

Otc - Purpose

PurposeOral Pain Reliever

* Please review the disclaimer below.