NDC 44224-0102 Adventure Medical Kits Dental Medic

Benzocaine

NDC Product Code 44224-0102

NDC 44224-0102-0

Package Description: 1 KIT in 1 BAG * .5 g in 1 PACKET (61010-8100-2)

NDC Product Information

Adventure Medical Kits Dental Medic with NDC 44224-0102 is a a human over the counter drug product labeled by Tender Corporation. The generic name of Adventure Medical Kits Dental Medic is benzocaine. The product's dosage form is kit and is administered via oral; topical form.

Labeler Name: Tender Corporation

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBIC ACID (UNII: X045WJ989B)

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.
  • 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: Tender Corporation
Labeler Code: 44224
FDA Application Number: part333A 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: 09-19-2012 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.

Adventure Medical Kits Dental Medic 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 - Oral Pain Relief

Benzocaine 20%

Purpose - Oral Pain Relief

Oral Pain Reliever

Uses - Oral Pain Reliever

Temporarily relieves pain caused by: toothache, dental work, minor irritation or injury of the mouth and gums, canker sores, cheek bites, gum sores, and denture irritation.

Warnings - Oral Pain Relief

For oral use only. Avoid contact with eyes.Allergy alertDo not use this product if you have a history of allergy to local anesthetics, such as procaine, butacaine, benzocaine, or other “caine” anesthetics due to the possibility of anaphylactic shock.When using this productDo not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.Keep out of reach of childrenIf more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions - Oral Pain Relief

Adults and children 2 years and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.Consult a dentist or doctor for use on children under 2 years of ageChildren under 12 years of age should be supervised in the use of this product

Other Information - Oral Pain Relief

Do not use if packet is torn, cut, or openedStore at room temperature, 15º to 30ºC (59º to 86ºF)Avoid contact with eyes

Inactive Ingredients - Oral Pain Relief

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

Keep Out Of Reach Of Children

Keep out of Reach of Children

* Please review the disclaimer below.