NDC 72837-0002 Leahue Madhuca

Salicylic Acid

NDC Product Code 72837-0002

NDC Product Information

Leahue Madhuca with NDC 72837-0002 is a a human over the counter drug product labeled by Bio-interchange Co.. The generic name of Leahue Madhuca is salicylic acid. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Bio-interchange Co.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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 Active Ingredient(s)

Additional informationCallout TooltipWhat 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 .2 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Product Label Images

Leahue Madhuca 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 Shampoo removes sebum and impurities from the scalp. to relieve the symptoms of hair loss

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Rinse your hair and scalp thoroughly with warm water. Apply an appropriate amount of product to the scalp and gently massage. Clean the product out of your hair thoroughly.

Warnings (Cautions)

  • If abnormal symptoms or side effects such as red spots, swelling and itching occur on the area of use due to exposure to sunlight, consult a specialist.Refrain cosmetic use on skin breaks and wounds.If the product gets in your eyes, immediately flush out your eyes with water.If the product is not rinsed thoroughly, it may cause hair loss or decolorization.Storage and Precautions for Handling *Keep out of reach of children. *Avoid storage in direct sunlight.

Dosage & Administration

For external use only

* Please review the disclaimer below.

Previous Code
72837-0001
Next Code
72840-1901