NDC 73799-001 Mobisyn Pain Relieving

Methyl Salicylate And Menthol

NDC Product Code 73799-001

NDC 73799-001-03

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 90 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Mobisyn Pain Relieving with NDC 73799-001 is a a human over the counter drug product labeled by Chrono Health Care Dba Natures Health Care. The generic name of Mobisyn Pain Relieving is methyl salicylate and menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Chrono Health Care Dba Natures Health Care

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Mobisyn Pain Relieving 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.

  • METHYL SALICYLATE 16 mg/100mL
  • MENTHOL, UNSPECIFIED FORM 8 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.

  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)

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: Chrono Health Care Dba Natures Health Care
Labeler Code: 73799
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: 09-22-2020 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.

Mobisyn Pain Relieving Product Label Images

Mobisyn Pain Relieving 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 Ingredients

Methyl salicylate 16%Menthol 8%

Purpose

Topical analgesic

Uses

  • Temporarily relieves minor pain associated with:arthritissimple backachemuscle strainssprainsbruisescramps

Warnings

For external use only.

When Using This Product

  • Use only as directed. •Read and follow all directions and warnings on this label.Avoid contact with eyes or mucous membranes.Do not bandage tightly or apply local heat (such as heating pads) to the area of application. •Do not apply to wounds or damaged, broken or irritated skin.Wash hands after use.

Stop Use And Ask A Doctor If:

Condition worsens or syptoms persist for more than 7 days or symptoms clear up and occur again with a few days. Excessive skin irritation occurs.

If Pregnant Or Breast-Feeding:

Ask a health professional before use.

Keep Out Of Reach Of Children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children over 12 years:Using the roll-on applicator, apply a thin layer to affected area. •Massage into painful area until thoroughly absorbed into skin. •Repeat as necessay, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications.AFTER APPLYING, WASH HANDS WITH SOAP AND WATERChildren 12 years or younger: Ask doctor

Inactive Ingredients

Acryloyldimethyltaurate/VP Copolymer, Arnica Extract, Caprylic/Capric Triglyceride, Cis-9-Cetylmyristoleate (CMO), Ethanol, Glucosamine HCL, Glycerin, Methylsulfonylmethane (MSM), Phenoxyethanol (and) Ethylhexylglycerin, Polysorbate 20, Witch Hazel, and Purified Water.

* Please review the disclaimer below.