NDC 73305-0001 Shineph

Chamaecyparis Obtusa Leaf

NDC Product Code 73305-0001

NDC 73305-0001-1

Package Description: 1.5 g in 1 APPLICATOR

NDC Product Information

Shineph with NDC 73305-0001 is a a human over the counter drug product labeled by Ch Bio Co., Ltd.. The generic name of Shineph is chamaecyparis obtusa leaf. The product's dosage form is liquid and is administered via vaginal form.

Labeler Name: Ch Bio 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.

Shineph 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.

  • LITHOSPERMUM OFFICINALE ROOT .7 g/100g
  • ARTEMISIA PRINCEPS LEAF OIL .6 g/100g
  • MAGNOLIA OFFICINALIS BARK .6 g/100g
  • CHAMAECYPARIS OBTUSA LEAF 1 g/100g

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.

  • Vaginal - Administration into the vagina.

Product Labeler Information

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

Labeler Name: Ch Bio Co., Ltd.
Labeler Code: 73305
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: 08-17-2019 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: 12-31-2020 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.

Shineph Product Label Images

Shineph 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

Chamaecyparis Obtusa Leaf extract, Lithospermum Officinale Extract, Magnolia Officinalis Bark Extract , Artemisia Princeps Leaf Extract , Glycyrrhiza Glabra (Licorice) Root Extract , Zingiber Officinale (Ginger) Root Extract , Rubus Coreanus Fruit Extract , Scutellaria Baicalensis Root Extract , Saussurea Involucrata Extract , Schisandra Chinensis Fruit Extract , Rhus Semialata Gall Extract , Coptis Chinensis Root Extract , Camellia Sinensis Leaf Extract

Inactive Ingredient

Water, Dipropylene Glycol, Glycerin, Niacinamide, Hydroxyethylcellulose, Butylene Glycol, Cellulose Gum, Asiaticoside, Yucca Vera Extract, Propolis Wax, Panthenol, Allantoin, Ethyl Hexanediol, Sodium Hyaluronate, Adenosine, Caprylyl Glycol, Citric Acid, Disodium EDTA, 1,2-Hexanediol

Otc - Purpose

Helps to clean the vulva and smell of women

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Hold the handle in the middle, and pull the shorter cap to the direction of arrow to separate as shown in the picture.Pull the other cap to the direction of arrow to separatePush the piston at the external genital slowly and absorb all the contents.Lightly rinse with water.

Warnings

1 In the use of the product if the following phenomenon happen, please stop using; if continue using the situation gets worse, please consult with the doctor

1) red, itchy, tingling

2) please stop using if any of the above symptoms appear because of the sun exposure

2 Wounds, eczema, skin inflammation in the face, please do not use

3 Storage precautions

1) seale immediately after using

2) please place in theplace where the infant are unable to access in case eating by mistake

3) avoid placing in high temperature, low temperature or direct sunlight field

Dosage & Administration

For vaginal use only

* Please review the disclaimer below.