NDC 77375-008 Cool And Heat Sore Muscle Roller Evora Labs

Menthol

NDC Product Code 77375-008

NDC 77375-008-02

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 74 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Cool And Heat Sore Muscle Roller Evora Labs with NDC 77375-008 is a a human over the counter drug product labeled by Evora Worldwide. The generic name of Cool And Heat Sore Muscle Roller Evora Labs is menthol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Evora Worldwide

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.

Cool And Heat Sore Muscle Roller Evora Labs 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 16 g/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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CAPSAICIN (UNII: S07O44R1ZM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALCOHOL (UNII: 3K9958V90M)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)

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: Evora Worldwide
Labeler Code: 77375
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: 12-21-2020 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.

Cool And Heat Sore Muscle Roller Evora Labs Product Label Images

Cool And Heat Sore Muscle Roller Evora Labs 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 Ingredient                                               Purpose

Menthol 16% ..................................................... Topical analgesic

Uses

Temporarily relieves minor pain associated with:


• arthritis • simple backache • muscle strains • sprains • bruises• cramps

Warnings

For externa use only.When using this product • use only as directed • do not


bandage tightly or use with a heating pad • avoid contact with


eyes and mucous membranes • do not apply to wounds or


damaged, broken or irritated skin • a transient burning sensation


may occur upon application but generally disappears in several


days • if severe burning sensation occurs, discontinue use


immediately • do not expose the area treated with product to heat


or direct sunlight


Stop use and ask doctor if • condition worsens • redness is


present • irritation develops • symptoms persist for more than 7


days or clear up and occur again within a few days


Flammable • keep away from fire or flame


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


use.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years: • apply generously to


affected area • massage into painful area until thoroughly


absorbed into skin • repeat as necessary, but no more than 3 to 4


times daily • IF MEDICINE COMES IN CONTACT WITH HANDS,


WASH WITH SOAP AND WATER


Children 12 years or younger: ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate


Crosspolymer, Capsaicin, Glycerin, lsopropyl Myristate, Propylene


Glycol, SD Alcohol 40 (30%), Triethanolamine, Water

Questions?

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* Please review the disclaimer below.