NDC 82371-008 Hand Cleanser

Hand Cleanser(amber)

NDC Product Code 82371-008

NDC 82371-008-01

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Hand Cleanser with NDC 82371-008 is a a human over the counter drug product labeled by Zhejiang Dibao Biotechnology Co., Ltd.. The generic name of Hand Cleanser is hand cleanser(amber). 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.

Hand Cleanser 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.

  • WATER (UNII: 059QF0KO0R)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • AMINO ACIDS, APRICOT KERNEL (UNII: 29W70FJS26)

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: 12-29-2021 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.

Hand Cleanser Product Label Images

Hand Cleanser 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

LAURETH-10 6%Glycerin 3%Amber extract 10.2%

Inactive Ingredient

Deionized waterAMINO ACIDS, APRICOT KERNELWHITE WAX

How To Use

Squeeze an appropriate amount of this product in your hands and scrub it, then rinse it with clean water.

Directions

This product is used to clean hands.Children should be supervised when using this product

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

Clean

Storage And Handling

Keep in a cool and dry place

Warnings

Do not take orally, for external use only.When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reach of children.

lf swallowed, get medical help or contact a Poison Control Center right away.

* Please review the disclaimer below.