NDC 81277-103 Zest Antibacterial Liquid Hand Lemon Peel

Benzalkonium Chloride

NDC Product Code 81277-103

NDC 81277-103-11

Package Description: 332 mL in 1 BOTTLE, PUMP

NDC Product Information

Zest Antibacterial Liquid Hand Lemon Peel with NDC 81277-103 is a a human over the counter drug product labeled by Tcp Hrb Holdings Llc. The generic name of Zest Antibacterial Liquid Hand Lemon Peel is benzalkonium chloride. The product's dosage form is soap and is administered via topical form.

Labeler Name: Tcp Hrb Holdings Llc

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Zest Antibacterial Liquid Hand Lemon Peel 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.

  • BENZALKONIUM CHLORIDE .13 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.

  • WATER (UNII: 059QF0KO0R)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • AGASTACHE FOENICULUM WHOLE (UNII: ZV7TA06J2V)
  • AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)
  • LEMON PEEL (UNII: 72O054U628)
  • ARABICA COFFEE BEAN (UNII: 3SW678MX72)
  • ROBUSTA COFFEE BEAN (UNII: V5032728L7)
  • ACEROLA (UNII: XDD2WEC9L5)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • MALIC ACID (UNII: 817L1N4CKP)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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: Tcp Hrb Holdings Llc
Labeler Code: 81277
FDA Application Number: part333E What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 12-16-2020 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.

Zest Antibacterial Liquid Hand Lemon Peel 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

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

For handwashing to decrease bacteria on the skin.

Warnings

FOR EXTERNAL USE ONLY.WHEN USING THIS PRODUCT, AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES WITH WATER.STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS.

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

  • Wet handsapply to palm of handscrub thoroughlyrinse thoroughly

Inactive Ingredients

Water/Aqua/Eau, Cetrimonium Chloride, Glycerin, Cocamide MEA, Lauramidopropylamine Oxide, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Myristamidopropylamine Oxide, Citric Acid, Fragrance/Parfum, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Agastache Mexicana Flower/Leaf/Stem Extract, Citrus Limon (Lemon) Peel Extract, Coffea Arabica (Coffee) Seed Extract, Coffea Robusta Seed Extract, Malpighia Glabra (Acerola) Fruit Extract, Glycolic Acid, Malic Acid, Yellow 5 (CI 19140), Yellow 6 (CI 15985)

* Please review the disclaimer below.