NDC 0363-1605 3x Medicated Mouth Sore Gel

Benzocaine

NDC Product Code 0363-1605

NDC CODE: 0363-1605

Proprietary Name: 3x Medicated Mouth Sore Gel 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: Benzocaine 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):
YELLOW (C48330 - CLEAR TO YELLOW TINT)
Flavor(s):
WINTERGREEN (C73424)

NDC Code Structure

  • 0363 - Walgreens

NDC 0363-1605-19

Package Description: 1 TUBE in 1 CARTON > 11.9 g in 1 TUBE

NDC Product Information

3x Medicated Mouth Sore Gel with NDC 0363-1605 is a a human over the counter drug product labeled by Walgreens. The generic name of 3x Medicated Mouth Sore Gel is benzocaine. The product's dosage form is gel and is administered via oral form.

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.

3x Medicated Mouth Sore 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.


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.

  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ALLANTOIN (UNII: 344S277G0Z)
  • WATER (UNII: 059QF0KO0R)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE K90 (UNII: RDH86HJV5Z)
  • SORBIC ACID (UNII: X045WJ989B)
  • SACCHARIN (UNII: FST467XS7D)

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.

Product Labeler Information

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

Labeler Name: Walgreens
Labeler Code: 0363
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: 10-20-2021 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.

3x Medicated Mouth Sore Gel Product Label Images

3x Medicated Mouth Sore 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

Benzocaine 20%Menthol 0.1%Zinc chloride 0.15%

Otc - Purpose

Oral pain relieverOral pain relieverOral astringent

Indications & Usage

Temporarily relieves pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums

Warnings

Methemoglobinemia 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) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue 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" anestheticsDo 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 ageStop 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

Dosage & Administration

Cut open tip of tube on score mark * do not use if tip is cut prior to opening * adults and children 2 years of age and older: apply to affected area 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

Inactive Ingredient

Allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

* Please review the disclaimer below.