NDC 72586-001 Dr Iyers Myorub

Camphor (synthetic), Menthol, Unspecified Form, And Capsaicin

NDC Product Code 72586-001

NDC 72586-001-01

Package Description: 50 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Dr Iyers Myorub with NDC 72586-001 is a a human over the counter drug product labeled by Activpower Inc.. The generic name of Dr Iyers Myorub is camphor (synthetic), menthol, unspecified form, and capsaicin. The product's dosage form is liniment and is administered via topical form.

Labeler Name: Activpower Inc.

Dosage Form: Liniment - A solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application.

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.

Dr Iyers Myorub 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.

  • CAMPHOR (SYNTHETIC) 100 mg/mL
  • MENTHOL, UNSPECIFIED FORM 50 mg/mL
  • CAPSAICIN .75 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.

  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CLOVE OIL (UNII: 578389D6D0)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • CURCUMIN (UNII: IT942ZTH98)
  • BLACK PEPPER OIL (UNII: U17J84S19Z)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • PEG-4 SORBITAN STEARATE (UNII: 90SOR12GHG)

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: Activpower Inc.
Labeler Code: 72586
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: 10-18-2018 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.

Dr Iyers Myorub 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

Other

Drug Facts

Covered by USPTO# US 15/852,768 and associated Foreign patent filings

Manufactured for/by ActivPower Inc.,Delaware, U.S.A under license from ActivPower Inc. 13505 Dulles Technology Drive, Suite 1A, Herndon, VA 20171, USA; www.activpowerinc.com

This BPA-Free container is made in chinaNet Quantity: 50ml

Otc - Purpose

Active IngredientPurposeCamphor 10%Topical analgesicMenthol 5%Topical analgesicCapsaicin 0.075%Topical analgesic

Uses

For application on to intact unbroken skin to help achieve the temporary relief of minor aches and pains of muscles, ligaments and joints such as joint discomfort, simple strains, minor soft tissue contusion and sprains, aches and pains associated with sport activity or exertion or for simple backache.

Warnings

For external use only.

When Using This Product

Avoid contact with eyes and mucous membranes, wounds, damaged or irritated skin. Do not bandage or cover with wrap or apply any heat or heating pad to area after use. Wash hands with soap and water after using this product.

Stop Use And Ask Doctor If

Condition worsens. Severe skin irritation occurs. Pain persists for more than 4 days. Pain clears up and then recurs after a few days.

If Pregnant Or Breast-Feeding

This product has not been tested in pregnant or breast-feeding women. Consult the advice of your doctor before using this product in these situations.

Keep Out Of Reach Of Children

Not recommended for use in children 12 years old or younger. If swallowed, get medical help or contact Poison Control immediately. If exposure to eyes, then wash copiously with cold water and consult a doctor. Components are not certified to be free of nut allergens. Do not use if allergic to nuts or peanuts or if allergic to any of the components without testing. Use on a small area for the first time. If rash or itching develops then discontinue use. If symptoms persist then consult a medical professional. If the intended area of application or joint is hot, red, bruised or swollen then do not apply this liniment and immediately seek professional medical help.

Inactive Ingredients

Eucalyptus Oil; Clove Oil; Frankincense Oil; Oleoresins of Cinnamon and Black Pepper; Curcumin; Ethanol; Castor Oil; Petrolatum

Directions For Use

For Topical use. Apply 2ml-3ml into target muscle area or joint and rub in gently until it vanishes. May apply up to twice daily. Do not exceed recommended frequency of application. Do not apply heat after application. This product will produce a soothing relief and sensation of heat and warmth in the area of application.

* Please review the disclaimer below.