NDC 54237-060 Hand Sanitizer Wipes

Hand Sanitizer Wipes

NDC Product Code 54237-060

NDC 54237-060-01

Package Description: 50 PACKET in 1 BAG > 10 mL in 1 PACKET

NDC Product Information

Hand Sanitizer Wipes with NDC 54237-060 is a a human over the counter drug product labeled by Guangzhou Daieme Cosmetic Co,.ltd. The generic name of Hand Sanitizer Wipes is hand sanitizer wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Guangzhou Daieme Cosmetic 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 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.

  • ISOPROPYL 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.

  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE (UNII: V5VD430YW9)
  • POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Guangzhou Daieme Cosmetic Co,.ltd
Labeler Code: 54237
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: 03-29-2021 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.

Hand Sanitizer Wipes Product Label Images

Hand 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

Otc - Active Ingredient

Lsopropyl Alcohol 75%

Warnings

For externial 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.lf 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. lf swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years & older:

Apply to hands

Ailow to dry without wiping

children under 2 years:

Ask a doctor before use

Otc - Purpose

Antiseptic

Inactive Ingredient

Water,Aloe Extract,VitaminE, Polyaminopropyl BiguanidePropylene glycol, Glycerin, Phenoxyethanol,Sodium Citrate

Indications & Usage

Help reduce bacteriathat potentially can cause disease.

* Please review the disclaimer below.