NDC 81615-005 Chinese Herb Essence Bacteriostatic Foaming Agent

Triclosan

NDC Product Code 81615-005

NDC CODE: 81615-005

Proprietary Name: Chinese Herb Essence Bacteriostatic Foaming Agent 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: Triclosan 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

  • 81615 - Jiangxi Renhetang Pharmaceutical Chain Co., Ltd.

NDC 81615-005-01

Package Description: 100 mL in 1 BOTTLE

NDC 81615-005-02

Package Description: 120 mL in 1 BOTTLE

NDC Product Information

Chinese Herb Essence Bacteriostatic Foaming Agent with NDC 81615-005 is a a human over the counter drug product labeled by Jiangxi Renhetang Pharmaceutical Chain Co., Ltd.. The generic name of Chinese Herb Essence Bacteriostatic Foaming Agent is triclosan. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Jiangxi Renhetang Pharmaceutical Chain 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.

Chinese Herb Essence Bacteriostatic Foaming Agent 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.

  • TRICLOSAN .11 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.

  • OSTHOL (UNII: XH1TI1759C)
  • SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
  • STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)
  • PHELLODENDRON CHINENSE WHOLE (UNII: QKA3ZK8IIE)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • 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.

Chinese Herb Essence Bacteriostatic Foaming Agent Product Label Images

Chinese Herb Essence Bacteriostatic Foaming Agent 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

CHINESE HERB ESSENCE BACTERIOSTATIC FOAMING AGENT

Active Ingredient(S)

TRICLOSAN 0.11g/100mL

Purpose

BACTERIOSTATIC

Use

Uses female intimate cleaning and daily hygiene care.

Warnings

This product is for external use only, not edible. This product cannot be used for STD prevention in sexual activity. Sediment after storage is completely natural. It does not affect usage effect. 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

Direct the outlet of the pump head at your palm and press. Apply the foam on your intimate area and rub gently, then rinse with clean water.

Other Information

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

Inactive Ingredients

OLIVE LEAF EXTRACT,SOPHORA FLAVESCENS,STEMONA TUBEROSA, FRUCTUS CNIDII,CORTEX PHELLODENDRI,ALOE SERUM, LACTIC ACID, UNSPECIFIED FORM, GLYCEROL, PURIFIED WATER

* Please review the disclaimer below.