NDC 81615-002 Zedoary Oils Feminine Antibacterial Gels

Chlorhexidine Diacetate

NDC Product Code 81615-002

NDC CODE: 81615-002

Proprietary Name: Zedoary Oils Feminine Antibacterial Gels What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Chlorhexidine Diacetate 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.

NDC Code Structure

NDC 81615-002-02

Package Description: 7 TUBE in 1 BOX > 5 g in 1 TUBE (81615-002-01)

NDC 81615-002-04

Package Description: 10 TUBE in 1 BOX > 2 g in 1 TUBE (81615-002-03)

NDC 81615-002-06

Package Description: 10 TUBE in 1 BOX > 3 g in 1 TUBE (81615-002-05)

NDC Product Information

Zedoary Oils Feminine Antibacterial Gels with NDC 81615-002 is a a human over the counter drug product labeled by Jiangxi Renhetang Pharmaceutical Chain Co., Ltd.. The generic name of Zedoary Oils Feminine Antibacterial Gels is chlorhexidine diacetate. The product's dosage form is gel and is administered via topical form.

Labeler Name: Jiangxi Renhetang Pharmaceutical Chain Co., Ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Zedoary Oils Feminine Antibacterial Gels 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.

  • CHLORHEXIDINE ACETATE .09 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.

  • ZEDOARY OIL (UNII: QPP5U30FSD)
  • OSTHOL (UNII: XH1TI1759C)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
  • STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)
  • 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.

Product Labeler Information

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

Labeler Name: Jiangxi Renhetang Pharmaceutical Chain Co., Ltd.
Labeler Code: 81615
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: 03-16-2021 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.

Zedoary Oils Feminine Antibacterial Gels Product Label Images

Zedoary Oils Feminine Antibacterial Gels 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

Other

ZEDOARY OIL FEMININE ANTIBACTERIAL GEL

Active Ingredient(S)

CHLORHEXIDINE DIACETATE 0.09g/100g

Purpose

BACTERIOSTATIC

Use

Uses for female daily intimate internal & external cleaning and hygiene care.

Warnings

Disposable product. Please do not use if the package is broken. This product is for external use only, not edible. Avoid contact with eyes This product cannot be used for STD prevention in sexual activity. Women who are in menstrual, gestational or perinatal periods should be used with extreme caution.

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.

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

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

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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

Directions

1.Take a supine position, and support the hip with a cushion. Remove the socket at the top of the injector and use it as the plunger rod. Slowly insert the gel injector containing antibacterial gel into the deep area of vagina. Deliver the gel into the vagina by pushing the plunger.

2.If there is discomfort in the intimate area, squeeze a little of the gel and apply onto the area, then gently rub for a while.

3.While in use, it’s normal to see vaginal discharge, so it’s recommended to use panty liners meanwhile.

4.Better effect can be obtained if FUYANJIE WASH is used before applying this product.

Other Information

This product can sterilize staphylococcus aureus, Escherichia coli, and Candida albicans.Keep in sealed container, and place in a cool dry place.

Inactive Ingredients

SOPHORA FLAVESCENS

STEMONA TUBEROSA

FRUCTUS CNIDII

ZEDOARY OIL

CARBOMER

PURIFIED WATER

* Please review the disclaimer below.