NDC 71351-018 Lidocaine Hcl

Lidocaine Hcl

NDC Product Code 71351-018

NDC 71351-018-01

Package Description: 1 TUBE in 1 CARTON > 28.3 g in 1 TUBE

NDC 71351-018-03

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC Product Information

Lidocaine Hcl with NDC 71351-018 is a a human over the counter drug product labeled by Brookfield Pharmaceuticals, Llc. The generic name of Lidocaine Hcl is lidocaine hcl. The product's dosage form is cream and is administered via topical form.

Labeler Name: Brookfield Pharmaceuticals, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Lidocaine Hcl 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.

  • LIDOCAINE HYDROCHLORIDE .03 g/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.

  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

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.
  • 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: Brookfield Pharmaceuticals, Llc
Labeler Code: 71351
FDA Application Number: part348 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: 11-14-2019 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.

Lidocaine Hcl Product Label Images

Lidocaine Hcl 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

Lidocaine HCl 3% w/w

Purpose

Topical anesthetic

Uses

  • Temporarily relieves pain and itching due tominor cutssunburnminor scrapesminor burnsinsect bitesminor skin irritations

Warnings

For external use only.

When Using This Product

  • Do not use in or near the eyesDo not use in large quantities, particularily over raw surfaces or blistered areas

Stop Use And Ask A Doctor If

  • Stop use and ask a doctor ifallergic reaction occurscondition worsens or does not improve in 7 dayssymptoms clear up and return within a few daysredness, irritation, swelling, pain or other symptoms begin or increase

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a dayChildren under 2 years ask a doctor

Other Information

  • May be applied under occlusive dressing.Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive Ingredients

Benzyl alcohol, carbomer, cholesterol, lecithin, polysorbate 80, propylene glycol, purified water, sodium hydroxide, titanium dioxide, tocopheryl acetate.

* Please review the disclaimer below.