NDC 0699-7081 Topex Mint

Benzocaine

NDC Product Code 0699-7081

NDC 0699-7081-01

Package Description: 100 g in 1 JAR

NDC Product Information

Topex Mint with NDC 0699-7081 is a a human prescription drug product labeled by Dentsply Llc. Professional Division Trading As "sultan Healthcare". The generic name of Topex Mint is benzocaine. The product's dosage form is gel, dentifrice and is administered via dental form.

Labeler Name: Dentsply Llc. Professional Division Trading As "sultan Healthcare"

Dosage Form: Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.

Product Type: Human Prescription 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.

Topex Mint 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 220 mg/g

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 400 (UNII: B697894SGQ)
  • SACCHARIN (UNII: FST467XS7D)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • SACCHARIN (UNII: FST467XS7D)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SACCHARIN (UNII: FST467XS7D)
  • WATER (UNII: 059QF0KO0R)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • SACCHARIN (UNII: FST467XS7D)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN (UNII: FST467XS7D)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • SACCHARIN (UNII: FST467XS7D)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • SACCHARIN (UNII: FST467XS7D)
  • WATER (UNII: 059QF0KO0R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • SACCHARIN (UNII: FST467XS7D)
  • WATER (UNII: 059QF0KO0R)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)

Administration Route(s)

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

  • Dental - Administration to a tooth or teeth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Allergens - [CS]

Product Labeler Information

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

Labeler Name: Dentsply Llc. Professional Division Trading As "sultan Healthcare"
Labeler Code: 0699
Marketing Category: UNAPPROVED DRUG OTHER - 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: 02-19-1963 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: 12-31-2019 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.

Topex Mint 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

DIRECTIONS FOR USEGel – 1oz/30mL
AD31001 Cherry

AD31002 Mint

AD31004 Pina Colada

AD31005 Bubble-Num

AD31006 Strawberry

AD31007 Razzberry
Gel – 100g jar
AD31064 Cherry

AD31964 Mint

AD31067 Pina Colada

AD31068 Bubble-Num
For dental use only.

Rx only.

1. Indications And Usage

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intraoral radiographs. Apply as required.

2. Dosage And Administration

  • Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottleTightly re-cap the jar after each use.

3. Dosage Forms And Strengths

Each gram of Topex Topical Anesthetic Gel contains between 180-220 mg benzocaine in a flavored base.

4. Contraindications

Do not use onindividuals with a known sensitivity to benzocaine or PABA.

5. Warnings And Precautions

  • METHEMOGLOBINEMIA WARNING:Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient in your care develops:pale, gray or blue colored skin (cyanosis)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energyNot for use in children under 2 years of age
  • Keep out of reach of children
  • For professional dental use only
  • Take care not to contaminate the jar by reintroducing a used cotton applicator into the jar

6. Overdosage

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

7. Description

Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.

8. How Supplied / Storage And Handling

Topex 20% benzocaine gel is supplied in multiple use containers.Store between 59°-86°F (15°-30°C). Protect from freezing.

Manufactured For

Sultan Healthcare1301 Smile Way • York, PA 17404 • USAToll Free: 800-637-8582 • Phone: 201-871-1232Fax: 201-871-0321 • www.sultanhealthcare.comMade in the USA

0031001DF, R4-072017

* Please review the disclaimer below.