NDC 37808-313 Heb Severe Toothache And Gum Relief Triple Medicated

Benzalkonium Chloride, Benzocaine, Menthol

NDC Product Code 37808-313

NDC Code: 37808-313

Proprietary Name: Heb Severe Toothache And Gum Relief Triple Medicated 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: Benzalkonium Chloride, Benzocaine, Menthol 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.

NDC Code Structure

  • 37808 - Heb
    • 37808-313 - Heb Severe Toothache And Gum Relief

NDC 37808-313-49

Package Description: 1 TUBE in 1 CARTON > 9.3 g in 1 TUBE

NDC Product Information

Heb Severe Toothache And Gum Relief Triple Medicated with NDC 37808-313 is a a human over the counter drug product labeled by Heb. The generic name of Heb Severe Toothache And Gum Relief Triple Medicated is benzalkonium chloride, benzocaine, menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Heb

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Heb Severe Toothache And Gum Relief Triple Medicated 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.

  • BENZALKONIUM CHLORIDE .1 g/100g
  • BENZOCAINE 20 g/100g
  • MENTHOL .25 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.

  • GELATIN (UNII: 2G86QN327L)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PECTIN (UNII: 89NA02M4RX)
  • SACCHARIN (UNII: FST467XS7D)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • 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: Heb
Labeler Code: 37808
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: 02-20-2019 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.

Heb Severe Toothache And Gum Relief Triple Medicated Product Label Images

Heb Severe Toothache And Gum Relief Triple Medicated 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

Other

Drug Facts

MADE WITH PRIDE AND CARE FOR H-E-B®SAN ANTONIO, TX 78204

Otc - Active Ingredient

Active ingredientsBenzocaine 20%Menthol 0.25%Benzalkonium Chloride 0.1%

Otc - Purpose

PurposeOral pain relieverOral pain relieverAntiseptic

Indications & Usage

  • Usefor the temporary relief of pain due to toothachesto help protect against infection of minor oral irritation

Warnings

  • WarningsMethemoglobenemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
  • Pale, gray, or blue colored skin (cyanosis)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energyAllergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

Otc - Do Not Use

  • Do not usemore than directedfor more than 7 days unless told to do so by a dentist or doctorfor teethingin children under 2 years of age

Otc - Stop Use

  • Stop use and ask a doctor ifswelling, rash or fever developsirritation, pain or redness persists or worsenssymptoms do not improve in 7 daysallergic reaction occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionscut open tip of tube on score markadults and children 2 years of age and older: apply a small amount of the product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctorchildren between 2 and 12 years of age should be supervised in the use of this productchildren under 2 years of age: do not use

Other Safety Information

  • Other informationdo not use if tip is cut prior to openingthis preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulteddo not use continuouslythis formula will stay in place for extended duration of reliefavoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive Ingredient

Inactive ingredientscellulose gum, gelatin, methyl salicylate, mineral oil, pectin, polyethylene glycol, sodium saccharin

* Please review the disclaimer below.

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