NDC 72826-102 Neuritrx

Capsaicin 0.075%

NDC Product Code 72826-102

NDC 72826-102-14

Package Description: 1 CONTAINER in 1 CARTON > 56.7 g in 1 CONTAINER

NDC Product Information

Neuritrx with NDC 72826-102 is a a human over the counter drug product labeled by Semprae Laboratories Inc. The generic name of Neuritrx is capsaicin 0.075%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Semprae Laboratories Inc

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.

Neuritrx 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.

  • CAPSAICIN .075 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.

  • ALMOND OIL (UNII: 66YXD4DKO9)
  • ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
  • CITRULLINE (UNII: 29VT07BGDA)
  • CINNAMON BARK OIL (UNII: XE54U569EC)
  • CORIANDER OIL (UNII: 7626GC95E5)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITOL (UNII: 506T60A25R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • 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.
  • 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: Semprae Laboratories Inc
Labeler Code: 72826
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: 11-29-2019 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.

Neuritrx Product Label Images

Neuritrx 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

Capsaicin 0.075%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:• simple backache • arthritis • strains • bruises • sprains

Warnings

For external use only

When Using This Product

• use only as directed• do not bandage tightly• do not use with heating pad• avoid contact with eyes and mucous membranes• do not apply to wounds, damaged, broken or irritated skin• a transient burning sensation may occur upon application but generally disappears in several days• if severe burning sensation occurs, discontinue use immediately• do not expose the area treated with product to heat or direct sunlight

Stop Use And Ask A Doctor If

• Condition worsens • Redness is present • Irritation develops • Symptoms persist for more than 7 days or symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children

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

Directions

Adults and children over 18 years: • Apply to affected area• Massage into painful area until thoroughly absorbed• Repeat as necessary, but no more than 3 to 4 times dailyChildren 18 years or younger: ask a doctor

Other Information

Store at 20° - 25°C (68° - 77°F)Do not use if inner container seal is damaged or missing.

Inactive Ingredients

Almond Oil, Benzyl Alcohol, Benzyl Benzoate, Butylated Hydroxytoluene, Carbomer Copolymer Type B, Cinnamon Bark Oil, Coriander Oil, Edetate Disodium, Isopropyl Alcohol, L-Arginine HCl, L-Citrulline , Polyoxl 40 Hydrogenated Castor Oil, Propylene Glycol, Sorbitol,Trolamine, Water

* Please review the disclaimer below.