NDC 73341-001 Blt Skin Cream

Benzocaine, Lidocaine, Tetracaine

NDC Product Code 73341-001

NDC CODE: 73341-001

Proprietary Name: Blt Skin Cream 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: Benzocaine, Lidocaine, Tetracaine 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 relieve nerve pain after shingles (infection with the herpes zoster virus). This type of pain is called post-herpetic neuralgia. Lidocaine helps to reduce sharp/burning/aching pain as well as discomfort caused by skin areas that are overly sensitive to touch. Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

NDC Code Structure

  • 73341 - M2b Pharma Llc

NDC 73341-001-30

Package Description: 30 g in 1 JAR

NDC Product Information

Blt Skin Cream with NDC 73341-001 is a a human over the counter drug product labeled by M2b Pharma Llc. The generic name of Blt Skin Cream is benzocaine, lidocaine, tetracaine. The product's dosage form is cream and is administered via topical form.

Labeler Name: M2b Pharma 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.

Blt Skin Cream 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 .2 g/g
  • TETRACAINE .01 g/g
  • LIDOCAINE .04 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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24)
  • BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: M2b Pharma Llc
Labeler Code: 73341
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: 02-04-2020 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: 12-31-2021 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.

Blt Skin Cream Product Label Images

Blt Skin Cream 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%

Lidocaine 4%

Tetracaine 1%

Purpose

Topical anesthetic

Topical analgesic

Topical analgesic

Uses

For temporary relief of pain

Warnings

For external use only

Do Not Use

  • On wounds or damaged, broken or irritated skinIn large quantitiesAt the same time as other topical analgesics or anestheticsIf you are currently taking medication to control heart rate or rhythm or if you have any type of heart diseaseIf you are allergic to PABA, benzocaine, lidocaine, tetracaine or other sulfonamides (sulfa) type drugsIf you are under the age of 17

When Using This Product

  • Use only as directed. Read and follow all directions and warnings on this label.Avoid contact with eyes or mucous membraneDo not bandage or cover with any type of clear occlusive dressingDo not apply heat (such as heating pad) to area of use

Stop Use And Ask A Doctor If

  • If redness or skin irritation is present at application siteCondition worsensSymptoms persist for more than 7 days or clear up and occur again within a few daysYou have any heart conditions

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children over 17 years of age:Apply to affected area of pain no more than 3-4 times per day. Do not cover with any occlusive dressingDo not use on children 17 years and younger without consulting a doctor.

Other Information

  • Store at 20-25 degrees C (68-77 degrees F).Store away from heat, sunlight, and excessive heat or humidity

Inactive Ingredients

Behentrimonium chloride, caprylic/capric triglyceride, cetearyl alcohol, citric acid, dimethyl isosorbide, ethylhexylglycerin, PEG-150 distearate, phenoxyethanol, polyquaternium-37, water

Questions?

1-877-760-1881info@bltskincream.com

* Please review the disclaimer below.