NDC 74166-300 Sooae Hand Santizing Wipes

Benzalkonium Chloride

NDC Product Code 74166-300

NDC 74166-300-20

Package Description: 20 CLOTH in 1 POUCH

NDC Product Information

Sooae Hand Santizing Wipes with NDC 74166-300 is a a human over the counter drug product labeled by Dkcos Corp. The generic name of Sooae Hand Santizing Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Dkcos Corp

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.

Sooae Hand Santizing 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.

  • BENZALKONIUM CHLORIDE .1 1/1

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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Dkcos Corp
Labeler Code: 74166
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: 04-30-2020 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.

Sooae Hand Santizing Wipes Product Label Images

Sooae Hand Santizing 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 0.1%

Purpose

Antiseptic handwash

Uses

  • For hand washing to decrease bacteria on the skin

Warnings

For external use only

Otc - Do Not Use

  • Do not useIf you are allergic to any of the ingredients

Otc - When Using

  • When using this productDo 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 childrenUnless under adult supervisionIf swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Use entire wipe to thoroughly wipe hands, fingers, and wristsTo sanitize, use multiple wipesDiscard after single useKeep label closed to prevent moisture loss

Other Information

  • Read the directions and warning before useAvoid freezing and excessive heat

Inactive Ingredients

Water (Aqua), Phenoxyethanol, Glycerin, Sodium Benzoate, Polysorbate 20, Disodium EDTA, Citric Acid, Tocopheryl Acetate

* Please review the disclaimer below.