NDC 78417-008 Merry Skin Be Hairful Tonic

Salicylic Acid

NDC Product Information

Merry Skin Be Hairful Tonic with NDC 78417-008 is a a human over the counter drug product labeled by Yegreena Co., Ltd.. The generic name of Merry Skin Be Hairful Tonic is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Yegreena 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.

Merry Skin Be Hairful 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 .25 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALCOHOL (UNII: 3K9958V90M)
  • C12-14 PARETH-12 (UNII: M0LJS773XW)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • ALLANTOIN (UNII: 344S277G0Z)
  • TREHALOSE (UNII: B8WCK70T7I)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • ARGININE (UNII: 94ZLA3W45F)
  • AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
  • AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
  • HOLY BASIL LEAF (UNII: SCJ765569P)
  • SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
  • TURMERIC (UNII: 856YO1Z64F)
  • CORALLINA OFFICINALIS (UNII: 4004498D06)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)
  • HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
  • BIOTIN (UNII: 6SO6U10H04)

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: Yegreena Co., Ltd.
Labeler Code: 78417
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: 09-24-2020 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.

Merry Skin Be Hairful Tonic Product Label Images

Merry Skin Be Hairful 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

Otc - Active Ingredient

Salicylic Acid 0.25%

Otc - Purpose

Anti-dandruff

Indications & Usage

Helps prevent recurrence of flaking and itching associated with dandruff

Dosage & Administration

Twice a day. Thoroughly shake hair tonic before use. Spray moderate amount of hair tonic and massage scalp using fingers absorbs well.

Warnings

For external use only.


When using this product, do not get into eyes. If contact occurs, rinse eyes thoroughly with water.


Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Inactive Ingredient

Water, Butylene Glycol, Alcohol Denat., C12-14 Pareth-12, Menthol, Allantoin, Trehalose, Panthenol, Arginine, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Fragrance, Ocimum Sanctum Leaf Extract, Saccharomyces Cerevisiae Extract, Curcuma Longa (Turmeric) Root Extract, Corallina Officinalis Extract, Disodium EDTA, 1,2-Hexanediol, Eriobotrya Japonica Leaf Extract, Houttuynia Cordata Extract, Biotin

* Please review the disclaimer below.