NDC 82371-003 Stain Remover

Stain Remover(bamboo)

NDC Product Code 82371-003

NDC 82371-003-01

Package Description: 8.9 mL in 1 BOTTLE

NDC Product Information

Stain Remover with NDC 82371-003 is a a human over the counter drug product labeled by Zhejiang Dibao Biotechnology Co., Ltd.. The generic name of Stain Remover is stain remover(bamboo). The product's dosage form is liquid and is administered via topical form.

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.

Stain Remover 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.


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.

  • SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
  • BETAINE (UNII: 3SCV180C9W)
  • WATER (UNII: 059QF0KO0R)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)

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: Zhejiang Dibao Biotechnology Co., Ltd.
Labeler Code: 82371
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: 12-28-2021 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.

Stain Remover Product Label Images

Stain Remover 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

C12-15 PARETH-10 5%Sodium dodecyl sulphate 8%OCTOXYNOL-11 4%Bamboo extract 10.2%

Inactive Ingredient

Deionized waterSodium phosphate, dibasic, dihydrateBetaineCoconut diethanolamide

How To Use

Step 1-Wipe the fresh stains with a tissue or cloth

Step 2- Roll the ball until the liquid completely covers the stain

Step 3- After 10 seconds, gently wipe the stain area witha damp cloth

Indications & Usage

Spray enough product where you need to clean up to cover the dirt.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

In addition to stains

Storage And Handling

Keep in a cool and dry place

Warnings

1.Do not directly expose the processed stain area to sunlight.

2.Keep out of reach of children.

3. If got into eyes, please rinse with plenty of water immediately. Ask doctor for help if necessary.

4. If swallowed, please go to the hospital immediately and show the doctor product container and label.

* Please review the disclaimer below.