NDC 36800-512 Topcare Oral Pain Relief Maximum Strength

Benzocaine

NDC Product Code 36800-512

NDC 36800-512-29

Package Description: 1 TUBE in 1 CARTON > 14 g in 1 TUBE

NDC Product Information

Topcare Oral Pain Relief Maximum Strength with NDC 36800-512 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Oral Pain Relief Maximum Strength is benzocaine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Topco Associates Llc

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.


Topcare Oral Pain Relief Maximum Strength 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.

  • 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.

  • SORBIC ACID (UNII: X045WJ989B)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • 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.

  • 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: Topco Associates Llc
Labeler Code: 36800
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: 03-05-2019 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.

Topcare Oral Pain Relief Maximum Strength Product Label Images

Topcare Oral Pain Relief Maximum Strength 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

DISTRIBUTED BY TOPCO ASSOCIATES LLCELK GROVE VILLAGE, IL 60057QUESTIONS" 1-888-423-0139topcare@topco.com www.topcarebrand.com

Otc - Active Ingredient

Active ingredientBenzocaine 20%

Otc - Purpose

PurposeOral Pain Reliever

Indications & Usage

  • Usefor the temporary relief of pain due to toothaches

Warnings

  • WarningsMethemoglobinemia 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, 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 scoremarkadults and children 2 years of age and older: apply a small amount of product to the cavity and around the 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 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 tempory expedient until a dentist can be consulteddo not use continuously

Inactive Ingredient

Inactive ingredients flavor, polyethylene glycol, sodium saccharin, sorbic acid

* Please review the disclaimer below.

Previous Code
36800-511
Next Code
36800-515