NDC 72978-102 Ion-to Scalp Cleanser S

Menthol

NDC Product Code 72978-102

NDC 72978-102-01

Package Description: 500 g in 1 BOTTLE, PUMP

NDC Product Information

Ion-to Scalp Cleanser S with NDC 72978-102 is a a human over the counter drug product labeled by Husazomo Usa. The generic name of Ion-to Scalp Cleanser S is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Husazomo Usa

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.

Ion-to Scalp Cleanser S 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 2.5 g/500g

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: Husazomo Usa
Labeler Code: 72978
Marketing Category: UNAPPROVED DRUG OTHER - 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: 06-10-2019 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.

Ion-to Scalp Cleanser S 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

Anti-dandruff

Keep Out Of Reach Of Children

Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Uses

Helps eliminate irritation and flaking associated with dandruff

Warnings

For external use onlyDo not use on damaged or broken scalpWhen using this productAvoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if rash or irritation on scalp develops and lasts.

Directions

After shampoo, apply suitable amount and gently massage onto scalp.

Leave it on for 3~5 minutes.
Rinse thoroughly with tepid water.

Inactive Ingredients

Water, Cetearyl Alcohol, Propylene Glycol, Stearamidopropyl Dimethylamine, Caprylic/Capric Triglyceride, Squalane, Alcohol Denat., Niacinamide, Cetyl Ethylhexanoate, Cetyl Ethylhexanoate, Diphenylsiloxy Phenyl Trimethicone, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Steartrimonium Chloride, Propylene Glycol, Octyldodeceth-16, Butyrospermum Parkii (Shea) Butter, Lauramidopropyl Betaine, Sodium Chloride, Salicylic Acid, Citric Acid, Climbazole, Mentha Piperita (Peppermint) Oil, Panthenol, Vanillyl Butyl Ether, Biotin, Urea, Disodium Phosphate, sh-Oligopeptide-2, sh-Polypeptide-1, sh-Polypeptide-9, 1,2-Hexanediol, Pentylene Glycol, Sodium Phosphate, Histidine, Lysine, Arginine, Cystine, Glutamic Acid, Glycine, Calcium Chloride, Potassium Iodide, Ferric Chloride, Zinc Chloride, Polyglyceryl-10 Laurate, Ethylhexylglycerin, Calcium Pantothenate, Folic Acid, Inositol, Pyridoxine HCl, Cyanocobalamin, Tocopherol, Glutathione, Copper Tripeptide-1, Oligopeptide-1

* Please review the disclaimer below.