NDC 11822-0615 4x Medicated Severe Toothache And Gum Gel

Benzocaine

NDC Product Information

4x Medicated Severe Toothache And Gum Gel with NDC 11822-0615 is a a human over the counter drug product labeled by Rite Aid. The generic name of 4x Medicated Severe Toothache And Gum Gel is benzocaine. The product's dosage form is gel and is administered via oral form.

Labeler Name: Rite Aid

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

4x Medicated Severe Toothache And Gum Gel 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 .13 g/100g
  • ZINC CHLORIDE .15 g/100g
  • MENTHOL .5 g/100g
  • BENZOCAINE 20 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.

  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SORBIC ACID (UNII: X045WJ989B)
  • SACCHARIN (UNII: FST467XS7D)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • GLYCYRRHIZIN (UNII: 6FO62043WK)

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.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Rite Aid
Labeler Code: 11822
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: 05-06-2020 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: 12-31-2021 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.

4x Medicated Severe Toothache And Gum Gel Product Label Images

4x Medicated Severe Toothache And Gum Gel 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 Ingredients PurposeBenzalkonium Chloride 0.13% .... Oral AntisepticBenzocaine 20% ......................... Oral Pain RelieverMenthol 0.5% .............................. Oral Pain RelieverZinc Chloride 0.15% .................... Oral Astringent

Use

Use * for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

Indications & Usage

WarningsMethemoglobinemia warning: use of this product ay cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in teh 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) * headache * rapid heart rate * shortness of breath * dizziness or lightneadedness * fatigue or lack of energy

Allergy 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 use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age

Otc - Stop Use

Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic 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.

Directions

* cut open tip of tube to score mark * adults and children 2 years of age and older: apply a small amount of product to teh cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use

Other Information

Other information * do not use if tip is cut prior to ening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use ontinuously * this formula will stay in place for extended duration of reilef * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive Ingredient

Ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid

* Please review the disclaimer below.