NDC 73498-021 Natures Willow Balm

Menthol

NDC Product Code 73498-021

NDC 73498-021-01

Package Description: 99 g in 1 TUBE

NDC Product Information

Natures Willow Balm with NDC 73498-021 is a a human over the counter drug product labeled by Wb Ventures Llc. The generic name of Natures Willow Balm is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Wb Ventures 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.

Natures Willow Balm 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 30 mg/g

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.

  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • SORBIC ACID (UNII: X045WJ989B)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • HELICHRYSUM GYMNOCEPHALUM WHOLE (UNII: 0369G6I64W)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

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: Wb Ventures Llc
Labeler Code: 73498
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: 01-28-2021 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.

Natures Willow Balm Product Label Images

Natures Willow Balm 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

Other

Drug Facts

Distributed by WB Ventures, Cold Springs, KY 41076For more information or to report a serious adverse event contact 1-888-609-4556

Active Ingredient

Menthol 3%

Purpose

External Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with- arthritis- simple backache- strains

Warnings

For external use onlyDo not use on wounds or damaged skin
When using this product- avoid contact with eyes- do not bandage tightly​Stop use and ask a doctor if- condition worsens- symptoms persist for more than 7 days or clear up and occur again within a few daysIf pregnant or breast-feeding, ask a health professional before use

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

Directions

Adults and children over 12 years of age: apply to affected area not more than 3 to 4 times daily.Children under 12 years of age: consult a physician.

Inactive Ingredients

Almond Oil, Camphor, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Eucalyptus Oil, Geranium Oil, Glyceryl Stearate SE, Helichrysum Gymnocephalum Oil, Isopropyl Palmitate, Jojoba Seed Extract, Lavender Oil, Palmitic Acid, Phenoxyethanol, Propanediol, Sorbic Acid, Spearmint Oil, Stearic Acid, Stearyl Alcohol, Sunflower Oil, Triethanolamine, Water, White Willow Bark Extract

* Please review the disclaimer below.