NDC 72393-202 Workvie

Lidocaine, Menthol

NDC Product Code 72393-202

NDC 72393-202-25

Package Description: 71 g in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Workvie with NDC 72393-202 is a a human over the counter drug product labeled by Marketites Llc. The generic name of Workvie is lidocaine, 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 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 1 g/100g
  • LIDOCAINE 4 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.

  • CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F)
  • DIMETHICONE 500 (UNII: 5L1VVC3K8O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • HORSE CHESTNUT (UNII: 3C18L6RJAZ)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • HARPAGOSIDE (UNII: 8KGS1DC5ZU)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • FRUIT BROMELAIN (UNII: F0ZCA6O9QT)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHAMOMILE (UNII: FGL3685T2X)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LEMON BALM OIL (UNII: MJ76269K9S)
  • LINDEN LEAF (UNII: RU6O456OJ1)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WILLOW BARK (UNII: S883J9JDYX)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
  • GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
  • AMMONIUM LAURETH-7 SULFATE (UNII: 9LPV636QCV)
  • MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
  • POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
  • ALMOND OIL (UNII: 66YXD4DKO9)

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: 05-01-2019 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: 12-31-2020 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 Product Label Images

Workvie 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 IngredientsLidocaine HCL 4% w/w Menthol 1% w/w

Otc - Purpose

PurposeTopical analgesicTopical analgesic

Indications & Usage

USES For temporary relief of pain.

Warnings

WarningsFor external use only. Avoid contact with eyes.

Otc - Do Not Use

Do not use in large quantities, particularly over raw surfaces, or blistered areas.

Otc - Ask Doctor

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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 breast feeding, ask a health professional.

Dosage & Administration

Directions 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 Safety Information

Other Informationstore in a cool dry place between (59-86°F) 15-30°Cdon't use if seal over cap is broken, torn or missing

Inactive Ingredient

Inactive IngredientsAloe Barbadensis Leaf Extract, Arnica Extract, Bromelain, C13-14 Isoparaffin, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Chamomile Extract, Devil's Claw Extract, Dimethicone, Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycol Stearate, Horse Chestnut Extract, Isopropyl Myristate, Laureth-7, Lemon Balm Extract, Linden Flower Extract, Menthyl Lactate, MSM, PEG 100 Stearate, Phenoxyethanol, Polyacrylamide, Rosemary Extract, Sweet Almond Oil, Water, Willow Bark Extract

Otc - Questions

Questions or commentsinfo@workvie.com

* Please review the disclaimer below.

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