NDC 72393-305 Workvie Work Pain Relief Therapy Cream

Menthol

NDC Product Code 72393-305

NDC 72393-305-04

Package Description: .14 g in 1 JAR

NDC Product Information

Workvie Work Pain Relief Therapy Cream with NDC 72393-305 is a a human over the counter drug product labeled by Marketites Llc. The generic name of Workvie Work Pain Relief Therapy Cream is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Marketites Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Workvie Work Pain Relief Therapy Cream 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 2 g/100g

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.

  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ARGININE (UNII: 94ZLA3W45F)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • ARNICA MONTANA (UNII: O80TY208ZW)

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: Marketites Llc
Labeler Code: 72393
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: 02-01-2021 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 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.

Workvie Work Pain Relief Therapy Cream Product Label Images

Workvie Work Pain Relief Therapy Cream 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 IngredientsMenthol 2.0% w/w

Otc - Purpose

Topical Analgesic

Indications & Usage

Use For temporary relief of pain

Warnings

WarningsFor external use only. Avoid contact with eyes.

Otc - Ask Doctor

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days, or new symptoms occur.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.



If pregnant or breastfeeding, ask a health professional.

Dosage & Administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor.

Other Information

Store in a cool dry place between 68º and 77ºF.Do not use if seal is broken, torn or missing.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Water, Stearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Chondroitin, Glucosamine Sulfate, Dimethyl Sulfone (MSM), Arnica Extract, Eucalyptus Globulus Leaf Oil, Peppermint Oil, L-Arginine, Glycol Stearate, Phenoxyethanol, Caprylyl Glycol

Questions

Distributed by Marketites LLCCoral Gables, FL 33134Made in the USAQuestions? info@aromalief.com

* Please review the disclaimer below.