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NDC 84260-006 Vaginal Essential Oil

Tea Tree Oil Liquid Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 84260-006?
  4. Vaginal Essential Oil Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
84260-006
Proprietary Name:
Vaginal Essential Oil
Non-Proprietary Name: [1]
Tea Tree Oil
Substance Name: [2]
Tea Tree Oil
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Guangzhou Lvying Biotechnology Co., Ltd
    Labeler Code:
    84260
    Product Label ID:
    1736ad1b-c316-e8a0-e063-6394a90ab008
    FDA Application Number: [6]
    505G(a)(3)
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    04-29-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 84260-006?

    The NDC code 84260-006 is assigned by the FDA to the product Vaginal Essential Oil which is a human over the counter drug product labeled by Guangzhou Lvying Biotechnology Co., Ltd. The generic name of Vaginal Essential Oil is tea tree oil. The product's dosage form is liquid and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 84260-006-01 10 ml in 1 bottle , 84260-006-02 15 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Vaginal Essential Oil?

    Take 5-8 drops of essential oil, drop on the shorts, to avoidrepeated cross-infection of external bacteria, causingvaginitis in young women. During menstruation, fake 5-8 drops of essential oil and put them on sanitary napkins to avoid repeated cross-infection of dirt. Flushing method: take 10-20 drops of essential oil anddissolve them in warm water (about 37%) and add them intoa disposable douche to do vaginal irrigation (beforemenstruation, after menstruation, before and after coitus)and irrigate before the use of gel in chronic inflammationperiod, which can promote the absorption of gel. Sitz bath method: vulvovaginifis ifching, odour can fake15-30 drops of essential oil, bath tub with boiling watercooled fo about 40 degrees, the amount of water over thebuttocks, and then the basin in the buttock bath for 10-15minutes that is.lt can be used for 10-15 minutes in thebathtub; Other applications: A. Environmental spraying: take 10-20 drops of essential oiland dilute them in a bottle containing 30ml of distilled waterand spray around the environment fo remove odours. B.Application: If you have an itchy scalp or pimples (similarto rashes), take a few drops and apply to the affected area.

    What are Vaginal Essential Oil Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • TEA TREE OIL 4 g/100mL - Essential oil extracted from MELALEUCA ALTERNIFOLIA (tea tree). It is used as a topical antimicrobial due to the presence of terpineol.

    Which are Vaginal Essential Oil UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Vaginal Essential Oil Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

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    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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".