NDC 73214-001 Carpal Comfort

Benzyl Alchohol, Lidocaine Hci

NDC Product Code 73214-001

NDC Code: 73214-001

Proprietary Name: Carpal Comfort 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: Benzyl Alchohol, Lidocaine Hci 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.

NDC Code Structure

  • 73214 - Comfort Lab, Lp
    • 73214-001 - Carpal Comfort

NDC 73214-001-01

Package Description: 1 TUBE, WITH APPLICATOR in 1 BOX > 88 mL in 1 TUBE, WITH APPLICATOR

NDC Product Information

Carpal Comfort with NDC 73214-001 is a a human over the counter drug product labeled by Comfort Lab, Lp. The generic name of Carpal Comfort is benzyl alchohol, lidocaine hci. The product's dosage form is cream and is administered via topical form.

Labeler Name: Comfort Lab, Lp

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.

Carpal Comfort 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.

  • BENZYL ALCOHOL 10 mg/100mL
  • LIDOCAINE HYDROCHLORIDE 4 mg/100mL

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.

  • ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • ALCOHOL (UNII: 3K9958V90M)
  • TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
  • CARBOMER 940 (UNII: 4Q93RCW27E)

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: Comfort Lab, Lp
Labeler Code: 73214
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: 07-10-2019 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.

Carpal Comfort 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

Otc - Active Ingredient

Benzyl Alcohol, Lidocaine HCl

Indications

For temporary relief of pain.

Warnings

  • For external use onlyAvoid contact with eyes

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, consult physician.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, contact physician prior to use.

Otc - Stop Use

If symptoms persist more than seven days, discontinue use and consult physician.

Additional Information

Store at room temperature.

Otc - Questions

Questions or comments? www.carpalcomfort.com

Otc - Purpose

Topical Anesthetic

Indications & Usage

LIDOCAINE HYDROCHLORIDEBENZYL ALCOHOLPOLYSORBATE 20PROPYLENE GLYCOLBOSWELLIA SERRATA RESIN OILILEX PARAGUARIENSIS LEAFMAGNESIUM SULFATE, UNSPECIFIEDSPEARMINT OILALCOHOLTRIETHANOLAMINE SULFATEXANTHAN GUMWATERPHENOXYETHANOLARNICA MONTANA FLOWER WATERDIMETHYL SULFONECARBOMER 980ETHOXYDIGLYCOL BEHENATE

Dosage & Administration

Adults and children two-years of age and older: Apply to affected area not more than three to four times a day.Children under two years of age:Consult a physician

Inactive Ingredient

LIDOCAINE HYDROCHLORIDEBENZYL ALCOHOLPOLYSORBATE 20PROPYLENE GLYCOLBOSWELLIA SERRATA RESIN OILILEX PARAGUARIENSIS LEAFMAGNESIUM SULFATE, UNSPECIFIEDSPEARMINT OILALCOHOLTRIETHANOLAMINE SULFATEXANTHAN GUMWATERPHENOXYETHANOLARNICA MONTANA FLOWER WATERDIMETHYL SULFONECARBOMER 980ETHOXYDIGLYCOL BEHENATE

* Please review the disclaimer below.

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