NDC 54826-006 Ethyl Alcohol Antiseptic Hand Wipes

Ethyl Alcohol Antiseptic Hand Wipes

NDC Product Code 54826-006

NDC CODE: 54826-006

Proprietary Name: Ethyl Alcohol Antiseptic Hand Wipes What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ethyl Alcohol Antiseptic Hand Wipes What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 54826 - Cixi Fanhua Non Woven Products Co., Ltd
    • 54826-006 - Ethyl Alcohol Antiseptic Hand Wipes

NDC 54826-006-01

Package Description: 60 PACKET in 1 BOX > 4.88 mL in 1 PACKET

NDC Product Information

Ethyl Alcohol Antiseptic Hand Wipes with NDC 54826-006 is a a human over the counter drug product labeled by Cixi Fanhua Non Woven Products Co., Ltd. The generic name of Ethyl Alcohol Antiseptic Hand Wipes is ethyl alcohol antiseptic hand wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Cixi Fanhua Non Woven Products 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.

Ethyl Alcohol Antiseptic Hand 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 75 mL/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.

  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • ALOE (UNII: V5VD430YW9)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Cixi Fanhua Non Woven Products Co., Ltd
Labeler Code: 54826
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: 05-31-2021 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.

Ethyl Alcohol Antiseptic Hand Wipes Product Label Images

Ethyl Alcohol Antiseptic Hand 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

Otc - Active Ingredient

Ethyl alcohol 75%

Otc - Purpose

Antiseptic

Directions

Open pouch by peeling back seal

wet hands thoroughly with product andallow to dry without wiping
reseal pouch after each use to preservemoisture

supervise children under 6 years of agewhen using this product to avoid swallowing

Inactive Ingredient

Alkly dimethyl benzyl ammonium chlorideAloe extractAlpha tocopherolDecyl glucosideGlycerinPhenoxyethanolPolysorbate 20water

Uses

Hand wipes to decrease bacteria on the skin

recommended for repeated use

for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Otc - Do Not Use

In children less than 12 months of age

on open skin wounds
as a baby wipe

Otc - When Using

When using this product . do not get into eyes. ln case of contact,rinse eyes thoroughly with water

Otc - Stop Use

Stop use and ask a doctor if. irritation and redness develop

condition persists 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 ControlCenter right away.

Other Information

Store below 110°F(43°C)

* Please review the disclaimer below.