NDC 73096-044 Harmony Flexible 4% Menthol Pain Relief Roll-on 1000mg

Menthol

NDC Product Code 73096-044

NDC CODE: 73096-044

Proprietary Name: Harmony Flexible 4% Menthol Pain Relief Roll-on 1000mg What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 73096 - Harmony Products Llc.

NDC 73096-044-01

Package Description: 70.8 g in 1 BOTTLE, PLASTIC

NDC 73096-044-02

Package Description: 85 g in 1 BOTTLE, PLASTIC

NDC Product Information

Harmony Flexible 4% Menthol Pain Relief Roll-on 1000mg with NDC 73096-044 is a a human over the counter drug product labeled by Harmony Products Llc.. The generic name of Harmony Flexible 4% Menthol Pain Relief Roll-on 1000mg is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Harmony Products 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.

Harmony Flexible 4% Menthol Pain Relief Roll-on 1000mg 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 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CAMPHOR OIL (UNII: 75IZZ8Y727)
  • HEMP (UNII: TD1MUT01Q7)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • WATER (UNII: 059QF0KO0R)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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.
  • 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: Harmony Products Llc.
Labeler Code: 73096
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: 10-24-2019 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.

Harmony Flexible 4% Menthol Pain Relief Roll-on 1000mg Product Label Images

Harmony Flexible 4% Menthol Pain Relief Roll-on 1000mg 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

Menthol 4%

Otc - Purpose

Menthol 4% ...............Topical Analgesic

Indications & Usage

Uses Temporary Relief from minor aches and pains of muscles and joints associated with, simple backache, strains, bruises, sprains

Warnings

For external use only

Otc - When Using

When using this productUse only as directed, do not bandage tightly or use with 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.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

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.

Dosage & Administration

DirectionsAdults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

Inactive Ingredient

Inactive ingredientsAloe Barbadensis Leaf ExtractArctium Lappa Root (Burdock) ExtractArnica Montana Flower ExtractBoswellia Carterii Resin ExtractCalendula Officinalis ExtractCamellia Sinensis Leaf ExtractCamphorCarbomerFD&C Blue #1FD&C Yellow #5Full Spectrum Industrial Hemp ExtractGlycerinIlex Paraguariensis (Mate) Leaf ExtractIsopropyl AlcoholIsopropyl MyristateMelissa Officinalis (Lemon Balm) Leaf ExtractSilicaTocopheryl AcetateTriethanolamineWater

* Please review the disclaimer below.