NDC 81653-001 Bunee Hair Growth Serum

Minoxidil

NDC Product Code 81653-001

NDC 81653-001-01

Package Description: 60 mL in 1 BOTTLE

NDC Product Information

Bunee Hair Growth Serum with NDC 81653-001 is a a human over the counter drug product labeled by Guangzhou Jianyuan Biological Technology Co., Ltd.. The generic name of Bunee Hair Growth Serum is minoxidil. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Guangzhou Jianyuan Biological Technology 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.

Bunee Hair Growth Serum 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.

  • MINOXIDIL 5 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.

  • CAPSAICIN (UNII: S07O44R1ZM)
  • PLATYCLADUS ORIENTALIS SEED (UNII: QDB7SF78HO)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • GINGER (UNII: C5529G5JPQ)
  • LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)
  • REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
  • FRAXINUS EXCELSIOR BARK (UNII: R6KCX5H8I2)
  • ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)
  • ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
  • BIOTIN (UNII: 6SO6U10H04)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • SAFFLOWER (UNII: 4VBL71TY4Y)
  • GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)

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: Guangzhou Jianyuan Biological Technology Co., Ltd.
Labeler Code: 81653
FDA Application Number: ANDA075357 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 03-05-2021 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.

Bunee Hair Growth Serum Product Label Images

Bunee Hair Growth Serum 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

Minoxidil

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center right away.

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Purpose

Promotes hair growth

Inactive Ingredient

Water, alcohol, Ginseng Extract, Ginger Extract, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT, FRAXINUS EXCELSIOR BARK EXTRACT, FRUCTUS ACEROLA EXTRACT, LIGUSTICUM CHUANXIONG ROOT EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT, Arctium Lappa L., ANGELICA SINENSIS ROOT EXTRACT, THUJA ORIENTALIS SEED EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, Capsaicin, Vitamin H (Biotin)

Use[S]

Hair growth serum to help firming hair root and balancing the head skin secretion, improve thescalp itching, remove the grease, clear the hair follicles to promote the hair growth, reduce the hair loss and broken hair, give you a healthy hair looks.

Directions

Put right amount of hair growth serum apply on the hairloss area or hair scalp, gentle to massage to help absort.1-2 times per day.

Other Information

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Otc - Do Not Use

Pregnant women and children.

on open skin wounds

Warnings

For adult external use only. Flammable. Keep away from heat or flame

* Please review the disclaimer below.