NDC 52083-713 Gumsol

Benzocaine, Zinc Chloride

NDC Product Code 52083-713

NDC 52083-713-01

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Gumsol with NDC 52083-713 is a a human over the counter drug product labeled by Kramer Novis. The generic name of Gumsol is benzocaine, zinc chloride. The product's dosage form is solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 485560.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Gumsol 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.

  • ASPARTAME (UNII: Z0H242BBR1)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL (UNII: L7T10EIP3A)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)

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: Kramer Novis
Labeler Code: 52083
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: 02-28-2014 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 - 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.

Gumsol Product Label Images

Gumsol 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 (in 30 mL)                    PurposeBenzocaine 5% ............................................. AnestheticZinc Chloride 0.1% ....................................... Astringent

Otc - Purpose

  • Uses Temporarily relieves:Toothache, canker sore, minor dental procedures, or minor mouth injury or irritation of the mouth and gums caused by dentures or orthodontic appliances.Sore gums due to teething in infants and children 4 months of age or older.

Warnings

WarningsDo not exceed recommended dosage. Avoid contact with eyes. Severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

Otc - Do Not Use

  • Do not use: (unless directed by a doctor)
  • For more than 7 days.If you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine of other "caine" anesthetics.Stop use and see a doctor promptly:If mouth symptoms do not improve in 7 daysIf irritation, pain, or redness persist or worsens If swelling, rash or fever develops

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directions:Dry affected area with absorbent cotton. Apply with cotton applicator or spray.Adults and children 12 years or over:Apply 4 times daily or as directed by a dentist or physician.Children under 12 years of age:Should be supervised in the usage of this product.Children under 2 years of age:Consult a dentist or physician.

Indications & Usage

Other information Phenylketonurics: Contains phenylalanine 2.5 mg/mLStore at controlled room temperature 15-30°C (59-86°F).Tamper Evident Feature: Do not use if imprinted foil seal over bottle opening is torn, broken, or missing.

Inactive Ingredient

Inactive ingredients: Aspartame, cetylpyridinium chloride, glycerin, menthol, methylparaben, peppermint flavor, propylene glycol, propylparaben, and water (purified).

Otc - Questions

Questions of comments?:Kramer-Novis, San Juan PR, 1-787-767-2072

* Please review the disclaimer below.