NDC 73440-2161 Burn Relief Gel

Lidocaine Hydrochloride

NDC Product Code 73440-2161

NDC 73440-2161-1

Package Description: 482.46 g in 1 BOTTLE

NDC Product Information

Burn Relief Gel with NDC 73440-2161 is a a human over the counter drug product labeled by Cross Brands Contract Filling. The generic name of Burn Relief Gel is lidocaine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Cross Brands Contract Filling

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.

Burn Relief Gel 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 2.4123 g/482.46g

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.

  • WATER (UNII: 059QF0KO0R)

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: Cross Brands Contract Filling
Labeler Code: 73440
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: 02-08-2021 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.

Burn Relief Gel Product Label Images

Burn Relief Gel 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

Lidocaine Hydrochloride 0.5%


Topical Anesthetic


Temporary relief of pain and itching. Helps to relieve and soothe pain from sunburn, minor burns, skin irritations, scrapes, insect bites.


For external use only

Other Warnings

Avoid Contact with eyes.

Stop Use And Ask A Doctor If:

Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Pregnancy/Breast-Feeding Warning

If pregnant or breast-feeding, as a health care professional before use.

Do Not Use

In large quantity, particularly over raw surfaces or areas with blisters.

Keep Out Of Reach Of Children.

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


Adults and children 2 years or older: apply generously to the burned area. Repeat application as often as necessary (no more than four times daily) to further extinguish pain. Children under 2 years of age: do not use, ask a doctor

Inactive Ingredients

Acrylates/C1030 alkyl acrylate crosspolymer, alcohol denatured, algae extract, aloe barbadensis leaf juice, butylene glycol, ehtylhexylglycerin, FD&C Blue No. 1, fragrance, glycerin, menthyl lactate, PEG-40 hydrogenated castor oil, phenoxyethanol, polysorbate 20, PPG-26-butheth-26, simmondsia chinensis (jojoba) extract, triethanolamine, water.

* Please review the disclaimer below.