NDC 80551-001 Burn Relief Aloe

Lidocaine Hcl

NDC Product Code 80551-001

NDC CODE: 80551-001

Proprietary Name: Burn Relief Aloe What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine Hcl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent and relieve pain during certain medical procedures (such as inserting a tube into the urinary tract). It is also used to numb the lining of the mouth, throat, or nose before certain medical procedures (such as intubation). Lidocaine jelly is also used to relieve pain caused by swelling of the urinary tract (urethritis). It works by numbing certain areas of the body that are moist. Lidocaine belongs to a class of drugs known as local anesthetics.

NDC Code Structure

NDC 80551-001-03

Package Description: 113 g in 1 BOTTLE

NDC Product Information

Burn Relief Aloe with NDC 80551-001 is a a human over the counter drug product labeled by Acutens. The generic name of Burn Relief Aloe is lidocaine hcl. The product's dosage form is gel and is administered via topical form.

Labeler Name: Acutens

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 Aloe 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 4 g/100g

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.

  • ALOE (UNII: V5VD430YW9)
  • OAT (UNII: Z6J799EAJK)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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: Acutens
Labeler Code: 80551
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: 03-18-2021 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 - NO 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 Aloe Product Label Images

Burn Relief Aloe 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                                         Purpose

LIDOCAINE HYDROCHLORIDE               Pain Reliever

Uses:

For temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

Warnings For External Use Only

When using this product • Avoid contact with eyes. Rinse with water if contact occurs.


Stop use and ask doctor if • symptoms persist for more than 7 days or clear up and occur again within a few days.


Do not use in large quantities, particularly over raw surfaces or blistered area

Direction

Adults and children over 2 years and older: • Apply to affected area not more than 3-4 times a day


• Children under 2 years old: consult a doctor

Inactive Ingredients

Aloe Barbadensis Leaf Extract


Avena Sativa (Oat) Kernel Extract


Blue 1


Caprylyl Glycol


Chlorphenesin


Dimethyl Isosorbide


Glycerin


Hydroxyethylcellulose


Isopropyl Alcohol


Phenoxyethanol


Polysorbate 20


Propanediol


Tocopheryl Acetate


Water

* Please review the disclaimer below.