NDC 82468-0001 The Fact-hfn Cooling Anti-hair Loss Tonicgel

Menthol, Salicylic Acid, Panthenol

NDC Product Code 82468-0001

NDC CODE: 82468-0001

Proprietary Name: The Fact-hfn Cooling Anti-hair Loss Tonicgel What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol, Salicylic Acid, Panthenol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 82468 - Gragem Inc.
    • 82468-0001 - The Fact-hfn Cooling Anti-hair Loss Tonicgel

NDC 82468-0001-1

Package Description: 150 mL in 1 BOTTLE

NDC Product Information

The Fact-hfn Cooling Anti-hair Loss Tonicgel with NDC 82468-0001 is a a human over the counter drug product labeled by Gragem Inc.. The generic name of The Fact-hfn Cooling Anti-hair Loss Tonicgel is menthol, salicylic acid, panthenol. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

The Fact-hfn Cooling Anti-hair Loss Tonicgel 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.


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.

  • WATER (UNII: 059QF0KO0R)

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: Gragem Inc.
Labeler Code: 82468
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: 12-24-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

The Fact-hfn Cooling Anti-hair Loss Tonicgel Product Label Images

The Fact-hfn Cooling Anti-hair Loss Tonicgel 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

Otc - Active Ingredient

Mentholsalicylic acidpanthenol

Inactive Ingredient

Water

Alcohol

Glycerin

PEG-60 Hydrogenated Castor Oil

Tromethamine

Carbomer

Trideceth-10

Fragrance

Butylene Glycol

1,2-Hexanediol

Caprylyl Glycol

Brassica Oleracea Italica (Broccoli) Extract

Illicium Verum (Anise) Fruit Extract

Sodium Hyaluronate

Geraniol

Linalool

Citronellol

Hexyl Cinnamal

Limonene

Otc - Purpose

Helps relieve and revitalizing scalp.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

After shampooing and before drying, apply an appropriate am

ount to the scalp in a wet state using your fingers and massage

so that it is fully absorbed. It ries commended to use it at least 3

times a week.

Warnings

1. If you have any of the following side effetsc while using, you

should stop using, iatnd if you continue to use, iytour sympt

oms will worsen, so consult your dermatologist.

-If there are side effects such as red spots, swelling, itching, irrita

tion during use.

-If the application area has the above side efftesc

due to direct sunlight

2. Do not use on areas with wounds, eczema or dermatitis.

3. Precautions for stoarge and handling

- Be sure to close the cap taefr use.

- Do not store where children may reach.

- Store in a place with high or low tempaeturre and out of dire

ct sunlight.

4. In case of contact with eyes, rinse immediately and consult

a physician.

5. People who have ever had allergies, please consult your dotc

or or pharmacist before use

6. Do not use on children under 3 years ogfe a.

7. People with hypersensitivity to salicylic acid or who hasa bdei

tes, blood circulation disorders, renala filure, infection, redness,

those who are pregnant or may become pregnant should av

oid using the pdrouct as the current symptoms may worsen

a fter use, such as skin or body hypersensitivity or skin adverse

reatcions (edema, inflammation, etc.). So please avoid using it.

- Product Liability Act (PL Act): Before use, be sure to read the

instructions for use and precautions.

Dosage & Administration

For external use only

* Please review the disclaimer below.