NDC 70512-105 Neuraxacin Neuromethacin

Menthol Roll-on

  1. Labeler Index
  2. Sola Pharmaceuticals
  3. NDC: 70512-105 Neuraxacin Neuromethacin

NDC Product Code 70512-105

NDC CODE: 70512-105

Proprietary Name: Neuraxacin Neuromethacin 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: Menthol Roll-on 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

  • 70512 - Sola Pharmaceuticals

NDC 70512-105-90

Package Description: 90 mL in 1 BOTTLE

NDC Product Information

Neuraxacin Neuromethacin with NDC 70512-105 is a a human over the counter drug product labeled by Sola Pharmaceuticals. The generic name of Neuraxacin Neuromethacin is menthol roll-on. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Sola Pharmaceuticals

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Neuraxacin Neuromethacin 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.
  • MENTHOL 30 mg/mL

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.
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • WATER (UNII: 059QF0KO0R)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)

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: Sola Pharmaceuticals
Labeler Code: 70512
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: 12-10-2020 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.

Neuraxacin Neuromethacin Product Label Images

Neuraxacin Neuromethacin 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

Menthol

Otc - Purpose

Topical Analgesic

Indications

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

Warnings

-For external use only.-Avoid contact with eyes.-If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children

-If swallowed, consult physician.-Do not apply to wounds or damaged skin.-Do not bandage tightly.

If Pregnant Or Breast Feeding

Contact physician prior to use.

Directions

-Adults and children two-years of age or older. Apply to affected area not more than three to four times daily.-Children under two-years of age, consult a physician.

Storage

Store at room temperature.

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montant Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Cannabis Sativa (Full Spectrum Hemp) Oil, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus Annus (Sunflower) Oil, Isopropyl Alcohol, Isopropyl Myristate, Methylsufonylmethane (MSM), Phenoxyethanol, Sorbitan Olivate, Stearic Acid, Xanthan Gum.

* Please review the disclaimer below.