NDC 54723-004 Franklynumb 3

Tetracaine

NDC Product Code 54723-004

NDC 54723-004-01

Package Description: 4 mL in 1 POUCH

NDC Product Information

Franklynumb 3 with NDC 54723-004 is a a human over the counter drug product labeled by Sambria Pharmaceuticals, Llc. The generic name of Franklynumb 3 is tetracaine. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1733865.

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.

Franklynumb 3 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.


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)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
  • EMU OIL (UNII: 344821WD61)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • LAURETH-7 (UNII: Z95S6G8201)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Sambria Pharmaceuticals, Llc
Labeler Code: 54723
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: 12-08-2021 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 - 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Franklynumb 3 Product Label Images

Franklynumb 3 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

Tetracaine 2%

Purpose

External Analgesic

Uses

For temporary relief of pain and itching due to minor skin irritations.

Warnings

For external use only.Avoid contact with eyes.Do not use in large quantities, particularly over the raw surfaces or blistered area 


Stop use and ask a doctor ifcondition worsens, or if symptoms persists for more than 7 days or clear up and occur again within the few days. Discontinue use.

Keep Out Of Reach Of Children

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

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times


daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate,


Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7,


Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,Polyacrylamide,
Propylene Glycol,StearicAcid,Triethanolamine.

Other Information

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.