NDC 60640-1900 Lollicaine Mint

Benzocaine

NDC Product Code 60640-1900

NDC 60640-1900-1

Package Description: 1 JAR in 1 CARTON > 28.35 g in 1 JAR

NDC Product Information

Lollicaine Mint with NDC 60640-1900 is a a human over the counter drug product labeled by Centrix, Inc.. The generic name of Lollicaine Mint is benzocaine. The product's dosage form is gel, dentifrice and is administered via dental form.

Labeler Name: Centrix, Inc.

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 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.

Lollicaine 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 200 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 3350 (UNII: G2M7P15E5P)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

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.

Product Labeler Information

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

Labeler Name: Centrix, Inc.
Labeler Code: 60640
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: 08-27-2019 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.

Lollicaine 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

Active Ingredients

Benzocaine 20%

Purpose

Oral Anesthetic

Use

  • LolliCaine is a flavored topical anesthetic gel featuring rapid onset, no systemic absorption and a 15 minute duration. LolliCaine is packaged in a 1-oz. jar.For the temporary relief of occasional minor irritation and pain, associated with:Sore mouth and throatUlcersMinor dental proceduresNeedle puncturesMinor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

  • For external use onlyMethemoglobinemia WarningUse 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 if you have a history of allergy to any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.Sore Throat Warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

Do Not Use

  • For teethingin children under 2 years of ageWhen using this product avoid contact with eyesIf pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Use appropriate applicator and apply gel to mucosa or gingival soft tissue. Wait one minute or until tissue feels numb before starting needle injection or other procedure. Do not exceed recommended dosage.Adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by dentist or doctor.Children under 12 years of age: should be supervised in the use of the product.Children under 2 years of age: do not use

Other Information

Store at 59° to 86º F (15º to 30º C)

Inactive Ingredients

Blue 1*, flavor, PEG-8, PEG-75, Red 3*, Red 33*, Red 40*, sodium saccharin, Yellow 10**contains one or more of these ingredients.

* Please review the disclaimer below.