NDC 54826-003 Sanitizer Wipes

Sanitizer Wipes

NDC Product Code 54826-003

NDC 54826-003-01

Package Description: 160 CLOTH in 1 BOX

NDC Product Information

Sanitizer Wipes with NDC 54826-003 is a a human over the counter drug product labeled by Cixi Fanhua Non Woven Products Co., Ltd. The generic name of Sanitizer Wipes is sanitizer 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.

Sanitizer 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 597 mL/1601

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)

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: Cixi Fanhua Non Woven Products Co., Ltd
Labeler Code: 54826
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: 09-05-2020 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.

Sanitizer Wipes Product Label Images

Sanitizer 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

Dosage & Administration

●Store between 15-30°C(59-86°F)

●Avoid freezing and excessive heat above 40°C(104°F)

Inactive Ingredient

Non-woven fabricpure waterQuaternary Ammonium Salt

Indications & Usage

Remove lid from container, Find center of wipe roll, remove first wipe for use, twist corner of next wipe into point and thread through the hole in the container lid.Dispense remaining wipes as necessary by pulling out at an angle. When not in use keep lid closed to prevent moisture loss.

Otc - Active Ingredient

Alcohol

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Purpose

Disinfection

Sterilization

No Rinseing

Warnings

Flammable. Keep away from fire or flame.For external use only.When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.Stop use and ask a doctor if iritation or rash appears and lasts.Keep out of reach of children. If swallowed, get medical help right away.

* Please review the disclaimer below.