NDC 61919-680 Dendracin Neurodendraxcin

Methyl Salicylate, Menthol And Capsaicin Lotion

NDC Product Code 61919-680

NDC 61919-680-02

Package Description: 60 mL in 1 BOTTLE

NDC 61919-680-04

Package Description: 120 mL in 1 BOTTLE

NDC Product Information

Dendracin Neurodendraxcin with NDC 61919-680 is a a human over the counter drug product labeled by Directrx. The generic name of Dendracin Neurodendraxcin is methyl salicylate, menthol and capsaicin lotion. The product's dosage form is lotion and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1116967 and 1116971.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Dendracin Neurodendraxcin 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.

  • DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • GINGER (UNII: C5529G5JPQ)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • BORAGE SEED OIL (UNII: F8XAG1755S)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • WATER (UNII: 059QF0KO0R)
  • BENZOCAINE (UNII: U3RSY48JW5)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETYL ALCOHOL (UNII: 936JST6JCN)

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: Directrx
Labeler Code: 61919
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: 09-14-2021 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".

* Please review the disclaimer below.

Dendracin Neurodendraxcin Product Label Images

Dendracin Neurodendraxcin 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

Methyl Salicylate 30%

Menthol 10%

Capsaicin 0.025%

Otc - Purpose

Topical Analgesic

Warnings

For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not allow treated skin to contact infants or pets. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products. May stain furniture.

Indications & Usage

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Otc - Stop Use

For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If pain clears up and then recurs in a few days. If itching or rash occurs.

Otc - Do Not Use

On cuts or infected skin, on children less than 12 years old, in large amounts, especially over raw or blistered skin, if allergic to any ingredients, PABA, aspirin products, or sulfa. Store below 90°F/32°C.

Inactive Ingredient

Water, benzocaine, glyceryl stearate, PEG 100 stearate, stearic acid, cetyl alcohol, propylene glycol, dimethyl sulfoxide, triethanolamine, poloxamer 407, aloe barbadensis gel, borage oil, ammonium acryloyldimethyltaurate, zingiber officinale root extract, methylparaben, propylparaben, soya lecithin, DMDM hydantoin sodium stearoyl glutamate.

Other

Manufactured for Physician’s Science and Nature Inc.

220 Newport Center Drive 11-634, Newport Beach, CA 92660
Made in the USA

Patent Pending

Dosage & Administration

Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If swallowed, call poison control. If placed into eyes, rinse with cold water and call a doctor.

* Please review the disclaimer below.