NDC 57483-301 Carvanum

Menthol

NDC Product Code 57483-301

NDC 57483-301-01

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 30 mL in 1 BOTTLE, PUMP

NDC Product Information

Carvanum with NDC 57483-301 is a a human over the counter drug product labeled by Innovus Pharmaceuticals, Inc.. The generic name of Carvanum is menthol. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Innovus Pharmaceuticals, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Carvanum 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 5 mg/1000mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • GARLIC (UNII: V1V998DC17)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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: Innovus Pharmaceuticals, Inc.
Labeler Code: 57483
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: 04-14-2021 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 - 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.

Carvanum 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 Ingredients

Menthol 0.5%

Purpose

Topical Analgesic

Uses

  • For the temporary relief minor aches and pains of muscles and joints associated with:simple backachesarthritisstrainsbruisessprains

Warnings

For External Use Only

Do Not Use

  • On wounds or damaged, broken or irritated skinwith a heating pad

When Using This Product

  • Avoid contact with eyes or mucous membranesdo not bandage tightly

Stop Use And Ask A Doctor If

Unintended effects occur

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Center immediately

Directions

  • Use only as directedAdults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.Children under 12 years of age: consult a doctor

Other Information

Store at RT. Do not purchase if outer seal is broken.

Inactive Ingredients

Alcohol Denat. (SD Alcohol 40-B), Allium Sativum (Garlic) Bulb Extract/Propylene glycol, Beeswax, Cetyl Alcohol, Ethylhexyl Palmitate, Glyceryl Stearate SE, Glyceryl Stearate/PEG-100 Stearate, Propylene Glycol, Poloxamer 407, Phenoxyethanol/Caprylyl Glycol/Ethylhexylglycerin/Hexylene Glycol, Potassium Hydroxide, Purified Water, Sodium Bicarbonate

* Please review the disclaimer below.