NDC 0283-0520 Hurricaine Topical Anesthetic

Benzocaine

NDC Product Code 0283-0520

NDC 0283-0520-34

Package Description: 4 SYRINGE, PLASTIC in 1 BOX > 1.5 g in 1 SYRINGE, PLASTIC (0283-0520-43)

NDC Product Information

Hurricaine Topical Anesthetic with NDC 0283-0520 is a a human over the counter drug product labeled by Beutlich Pharmaceuticals, Llc. The generic name of Hurricaine Topical Anesthetic is benzocaine. The product's dosage form is gel and is administered via dental; oral; periodontal form.

Labeler Name: Beutlich Pharmaceuticals, 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.

Hurricaine Topical Anesthetic 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 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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.
  • Oral - Administration to or by way of the mouth.
  • Periodontal - Administration around a tooth.

Product Labeler Information

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

Labeler Name: Beutlich Pharmaceuticals, Llc
Labeler Code: 0283
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: 01-31-2021 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 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.

Hurricaine Topical Anesthetic Product Label Images

Hurricaine Topical Anesthetic 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 Ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

  • For the temporary relief of occasional minor irritation and pain, associated with:canker soressore mouth and throatminor injury of the mouth and gumsminor dental proceduresminor irritation of the mouth and gums caused by dentures or orthodontic appliances

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 energy


Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.


Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

Do Not Use

  • Do not use:if the tray seal is broken or missingfor teethingin children under 2 years of age

When Using This Product

  • Avoid contact with eyes

Keep Out Of Reach Of Children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Directions:Do not exceed recommended dosage.adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then spit out. 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 the productchildren under 2 years of age: do not use

Other Information

  • Store at 20°-25° C (68°-77° F)

Inactive Ingredients

  • Flavor, polyethylene glycol, sodium saccharin

* Please review the disclaimer below.