NDC 74168-004 Hand Sanitizing Wipes

Benzalkonium Chloride

NDC Product Code 74168-004

NDC 74168-004-01

Package Description: 1 CLOTH in 1 BAG

NDC 74168-004-02

Package Description: 5 CLOTH in 1 BAG

NDC 74168-004-03

Package Description: 8 CLOTH in 1 BAG

NDC 74168-004-04

Package Description: 10 CLOTH in 1 BAG

NDC 74168-004-05

Package Description: 20 CLOTH in 1 BAG

NDC 74168-004-06

Package Description: 36 CLOTH in 1 BAG

NDC 74168-004-07

Package Description: 40 CLOTH in 1 BAG

NDC 74168-004-08

Package Description: 45 CLOTH in 1 BAG

NDC 74168-004-09

Package Description: 50 CLOTH in 1 BAG

NDC 74168-004-10

Package Description: 60 CLOTH in 1 BAG

NDC 74168-004-11

Package Description: 80 CLOTH in 1 BAG

NDC 74168-004-12

Package Description: 80 CLOTH in 1 BAG

NDC 74168-004-13

Package Description: 120 CLOTH in 1 BAG

NDC 74168-004-14

Package Description: 150 CLOTH in 1 BAG

NDC 74168-004-15

Package Description: 160 CLOTH in 1 BAG

NDC 74168-004-16

Package Description: 200 CLOTH in 1 BAG

NDC 74168-004-17

Package Description: 240 CLOTH in 1 BAG

NDC 74168-004-18

Package Description: 280 CLOTH in 1 BAG

NDC 74168-004-19

Package Description: 320 CLOTH in 1 BAG

NDC 74168-004-20

Package Description: 20 CLOTH in 1 CANISTER

NDC 74168-004-21

Package Description: 40 CLOTH in 1 CANISTER

NDC 74168-004-22

Package Description: 45 CLOTH in 1 CANISTER

NDC 74168-004-23

Package Description: 50 CLOTH in 1 CANISTER

NDC 74168-004-24

Package Description: 60 CLOTH in 1 CANISTER

NDC 74168-004-25

Package Description: 80 CLOTH in 1 CANISTER

NDC 74168-004-26

Package Description: 100 CLOTH in 1 CANISTER

NDC 74168-004-27

Package Description: 120 CLOTH in 1 CANISTER

NDC 74168-004-28

Package Description: 150 CLOTH in 1 CANISTER

NDC 74168-004-29

Package Description: 160 CLOTH in 1 CANISTER

NDC 74168-004-30

Package Description: 200 CLOTH in 1 CANISTER

NDC 74168-004-31

Package Description: 240 CLOTH in 1 CANISTER

NDC 74168-004-32

Package Description: 280 CLOTH in 1 CANISTER

NDC 74168-004-33

Package Description: 20 CLOTH in 1 CONTAINER

NDC 74168-004-34

Package Description: 40 CLOTH in 1 CONTAINER

NDC 74168-004-35

Package Description: 45 CLOTH in 1 CONTAINER

NDC 74168-004-36

Package Description: 50 CLOTH in 1 CONTAINER

NDC 74168-004-37

Package Description: 60 CLOTH in 1 CONTAINER

NDC 74168-004-38

Package Description: 80 CLOTH in 1 CONTAINER

NDC 74168-004-39

Package Description: 100 CLOTH in 1 CONTAINER

NDC 74168-004-40

Package Description: 120 CLOTH in 1 CONTAINER

NDC 74168-004-41

Package Description: 150 CLOTH in 1 CONTAINER

NDC 74168-004-42

Package Description: 160 CLOTH in 1 CONTAINER

NDC 74168-004-43

Package Description: 200 CLOTH in 1 CONTAINER

NDC 74168-004-44

Package Description: 240 CLOTH in 1 CONTAINER

NDC 74168-004-45

Package Description: 280 CLOTH in 1 CONTAINER

NDC Product Information

Hand Sanitizing Wipes with NDC 74168-004 is a a human over the counter drug product labeled by Zhejiang Yasili Cosmetics Co., Ltd.. The generic name of Hand Sanitizing Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Zhejiang Yasili Cosmetics Co., Ltd.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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 Sanitizing Wipes 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.

  • ALCOHOL .33 g/1
  • BENZALKONIUM CHLORIDE 4.888 mg/1

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)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Zhejiang Yasili Cosmetics Co., Ltd.
Labeler Code: 74168
FDA Application Number: part333A 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: 05-27-2020 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.

Hand Sanitizing Wipes Product Label Images

Hand Sanitizing Wipes 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

Antimicrobial

Uses

For hand washing to decrease bacteria on the skin

Warnings

For external use only

Otc - Do Not Use

Do not use if you are allergic to any of the ingredients

Otc - When Using

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

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

  • Adults and children 2 years and over:apply to handsallow to dry without wipingChildren under 2 years ask a doctor before use

Inactive Ingredients

Water, alcohol, tocopheryl acetate, chlorphenesin, ethylhexylglycerin, fragrance

Beyond Sanitizing Wipes

AntibacterialKills GermsEffectively kills germs on handsPre moistenedSoft and cleanFast sterilizationPearl nonwoven clothHigh-efficient sterilizationRO purified waterEffectively kills: staphylococcus aureus, escherichia coli, pesudomonas aeruginosa, enterococcus hirae

Storage

  • Storage. Store at room temperature.Use. Apply wipe thoroughly to hands as desired.Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.Distributed by: Better than Better Inc. CA 91732Made in ChinaWarning: Cancer and Reproductive Harm - www.p65warnings.ca.gov.

* Please review the disclaimer below.