NDC 76731-203 Celgen Advanced Hair Tonic

Menthol

NDC Product Code 76731-203

NDC 76731-203-01

Package Description: 150 mL in 1 BOTTLE, SPRAY

NDC Product Information

Celgen Advanced Hair Tonic with NDC 76731-203 is a a human over the counter drug product labeled by Bbhc Co., Ltd. The generic name of Celgen Advanced Hair Tonic is menthol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Bbhc Co., Ltd

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.

Celgen Advanced Hair 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.

  • MENTHOL .25 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.

  • HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
  • ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • WATER (UNII: 059QF0KO0R)
  • REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
  • GINKGO (UNII: 19FUJ2C58T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • PULSATILLA CERNUA ROOT (UNII: FY35I16MPL)
  • ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)
  • HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV)
  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)
  • LUFFA AEGYPTIACA FRUIT (UNII: QKL9NEO1F9)
  • ALCOHOL (UNII: 3K9958V90M)
  • MORUS ALBA BARK (UNII: 7O71A48NDP)
  • PINUS SYLVESTRIS LEAFY TWIG (UNII: Q1RGP4UB73)
  • USNEA BARBATA (UNII: D6DVA9TCAP)

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: Bbhc Co., Ltd
Labeler Code: 76731
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: 08-31-2020 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: 12-31-2021 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.

Celgen Advanced Hair Tonic Product Label Images

Celgen Advanced Hair 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

Menthol 0.25%

Purpose

Hair Tonic

Uses

Helps prevent hair loss and thicken hair. Keeps scalp clean, healthy and smooth.

Warnings

For external use only.Store at room temperature.

Do Not Use

On damaged or broken scalp.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

Rash or irritation on scalp develops and lasts.

Keep Out Of Reach Of Children

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

Directions

Shake well before use. Spray the product on your scalp several times with your fingertips.

Inactive Ingredients

Alcohol, Water, Propylene Glycol, Polygonum Multiflorum Root Extract, Morus Alba Bark Extract, Ginkgo Biloba Leaf Extract, Pinus Sylvestris Bud Extract, Usnea Barbata (Lichen) Extract, Pulsatilla Koreana Extract, Zanthoxylum Piperitum Fruit Extract, PEG-40 Castor Oil, Butylene Glycol, Polysorbate 20, Fragrance, Hydrolyzed Corn Protein, Hydrolyzed Soy Protein, Hydrolyzed Wheat Protein, Camphor, Propanediol, Caprylhydroxamic Acid, Hydrolyzed Silk, Acorus Calamus Root Extract, Propolis Extract, Luffa Cylindrica Fruit/Leaf/Stem Extract, Sodium Chloride, Glucose

* Please review the disclaimer below.