NDC 72837-0001 Leahue Madhuca Tonic

Salicylic Acid

NDC Product Code 72837-0001

NDC Product Information

Leahue Madhuca Tonic with NDC 72837-0001 is a a human over the counter drug product labeled by Bio-interchange Co.. The generic name of Leahue Madhuca Tonic is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Bio-interchange Co.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.


Leahue Madhuca Tonic 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.

  • SALICYLIC ACID .6 g/100mL

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.

  • MENTHOL (UNII: L7T10EIP3A)
  • ALCOHOL (UNII: 3K9958V90M)

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: Bio-interchange Co.
Labeler Code: 72837
FDA Application Number: part358H 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-06-2019 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.

Leahue Madhuca Tonic Product Label Images

Leahue Madhuca Tonic 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 Ingredient

Salicylic Acid

Inactive Ingredients

Menthol, Water, Alcohol, etc

Purpose

Leahue Tonic helps to relieve the symptoms of hair loss, dandruff, and utching while provides a moist and shiny hair.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Shake the product well before use. Spray an appropriate amount of product on your scalp and gently massage with your fingers to allow the product to be absorbed. Use two to three times per day.

Warnings (Cautions)

  • Stop use and ask a doctor incase. *condition worsens. *redness is present. *irritation develops.Don’t apply to wounded or damaged skin.When using this product. *use only as directed. *avoid contact with eyes.Handle & Precautions 1) Keep out of reach of children. 2) For external use only. Store at room temperature.If you have a history of allergic symptoms, consult your doctor and/or pharmacist before use.Do not use this product on children under the age of three.Persons who have hypersensitivity to salicylate, diabetes, poor blood circulation, kidney failure, infection, inflammation, skin abnormalities, and/or pregnant or likely to become pregnant should not use this product.

Dosage & Administration

For external use only

* Please review the disclaimer below.

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