NDC 53145-081 Mascura La Vaca Plus

Methyl Salicylate

NDC Product Code 53145-081

NDC 53145-081-03

Package Description: 86 g in 1 JAR

NDC Product Information

Mascura La Vaca Plus with NDC 53145-081 is a a human over the counter drug product labeled by Menper Distributors, Inc.. The generic name of Mascura La Vaca Plus is methyl salicylate. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1101920.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Mascura La Vaca Plus 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.

  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • D&C YELLOW NO. 11 (UNII: 44F3HYL954)
  • MENTHOL (UNII: L7T10EIP3A)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WHITE PETROLATUM (UNII: B6E5W8RQJ4)

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: Menper Distributors, Inc.
Labeler Code: 53145
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: 06-19-2019 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: 12-31-2022 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.

Mascura La Vaca Plus Product Label Images

Mascura La Vaca Plus 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

Active ingredients   PurposeMethyl Salicylate 10.5%...............External analgesic

Otc - Purpose

PurposeExternal analgesic

Indications & Usage

  • UsesFor temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains and sprains.

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not useon wounds or damaged skinwith a heating padon a child under 12 years of ageover extensive areas of the bodyon irritated skinwith a bandage

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area.

Otc - When Using

  • When using this productavoid contact with eyes or mucous membranesdo not bandage

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens or symptoms persists for more than 7 dayssymptoms clear up and occur again within a few daysexcessive skin irritation occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning. If swallowed, induce vomiting and call a physician or contact a Posion Control Center right away.

Dosage & Administration

  • Directionsuse only as directedadults and children 12 years and older: apply to affected area not more than 3 to 4 times dailychildren under 12 years of age: ask a doctor.Other informationstore at 15 to 25 C (59 to 77 F)

Inactive Ingredient

Inactive ingredientsCamphor, D&c red #17, fragrance, menthol, methylparaben, paraffin wax, propylparaben, and white petrolatum.

Otc - Questions

Questions: Call 1-800-560-5223 M-F 9AM to 4PM Eastern

* Please review the disclaimer below.