NDC 78771-103 Accent Plus Hand Cleaner

Antibacterial Hand Wash

NDC Product Code 78771-103

NDC 78771-103-11

Package Description: 350 mL in 1 BOTTLE

NDC Product Information

Accent Plus Hand Cleaner with NDC 78771-103 is a a human over the counter drug product labeled by President Lin Co. Ltd.. The generic name of Accent Plus Hand Cleaner is antibacterial hand wash. The product's dosage form is lotion and is administered via topical form.

Labeler Name: President Lin Co. Ltd.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Accent Plus Hand Cleaner 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.

  • LAURAMIDOPROPYL BETAINE 1.2 mg/100mL
  • METHYL LACTATE, L- .03 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURETH-2 SULFATE (UNII: ZZQ59TY3KG)
  • SEA SALT (UNII: 87GE52P74G)

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.
  • 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: President Lin Co. Ltd.
Labeler Code: 78771
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: 08-31-2020 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: 12-31-2021 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.

Accent Plus Hand Cleaner 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 - Keep Out Of Reach Of Children

350ml NDC:78771-103-11keep out of reach of children

Warnings

350ml NDC:78771-103-11

WARNINGS

Note: Keep out of reach of children.

If accidentally swallowed, please bring the packing

box and seek medical treatment.

Keep away from eyes. If the product gets into eyes,

rinse thoroughly with water.

Dosage & Administration

350ml NDC:78771-103-11 DOSAGE & ADMINISTRATION

Inactive Ingredient

350ml NDC:78771-103-11INACTIVE INGREDIENT

Indications & Usage

350ml NDC:78771-103-11INDICATION & USAGE

Otc - Purpose

350ml NDC:78771-103-11 IT IS NEW

Otc - Active Ingredient

350ml NDC:78771-103-11 OTC-ACTIVE INGREDIENT

* Please review the disclaimer below.