NDC 79549-201 Vi. Clean

Cypress Oil, Eucalyptus Oil, Coral Calcium (ct-ccp50)

NDC Product Code 79549-201

NDC 79549-201-01

Package Description: 60 mL in 1 BOTTLE, SPRAY

NDC 79549-201-02

Package Description: 300 mL in 1 BOTTLE, SPRAY

NDC Product Information

Vi. Clean with NDC 79549-201 is a a human over the counter drug product labeled by Gdp International Co., Ltd. The generic name of Vi. Clean is cypress oil, eucalyptus oil, coral calcium (ct-ccp50). The product's dosage form is liquid and is administered via topical form.

Labeler Name: Gdp International 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.

Vi. Clean 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.

  • EUCALYPTUS OIL .1 g/100mL
  • CUPRESSUS SEMPERVIRENS LEAF OIL .5 g/100mL
  • CALCIUM HYDROXIDE .0053 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.

  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • 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.
  • 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: Gdp International Co., Ltd
Labeler Code: 79549
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: 07-13-2020 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.

Vi. Clean 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[S]

Cypress oil 0.5%Eucalyptus oil 0.1%Coral calcium (CT-CCP50) 0.0053%

Purpose

Disinfection

Use[S]

Disinfection and odor elimination of indoor spaces and objects.

Warnings

For external use only.

Do Not Use

For the purpose other than described above.

When Using This Product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

If appears any allergic symptom.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right way.

Directions

Shake the product well and spray at 30~40 cm distance from the place where needs disinfection or elimination of odor.

Other Information

- Store at room temperature- Avoid freezing and excessive heat above 40C

Inactive Ingredient

Polysorbate 80, water

[Precautions]

[General matter] Check the indications before use. Follow the indicated method of use and standard amount to spray. Do not let the contents come into contact with your eyes.[Exposure on human body] Do not inhale or drink.[Purpose of use] Do not use other than the purpose of the product indicated in the label. Do not arbitrarily change the container.[Leakage of content] If the container is fallen down, the liquid may leak. Do not neglect it and do not give impact such as dropping.[Storage] Keep away from fire or heat. Store in a cool place away from direct sunlight, and keep the lid closed after use.[Emergency measure] If you are exposed to the product and feel uncomfortable, seek help from a medical institution (doctor). If you inhale it and feel difficulty in breathing, move to a place where you can get fresh air and rest with a breathable position.[Others] White stains may appear after the solution dries. The white stain is a calcium carbonate produced by the natural reaction of coral calcium solution with oxygen, so it is not defect or pigment in the product.

* Please review the disclaimer below.