NDC 79600-001 Disinfectant Wipes

Disinfectant Wipes

NDC Product Code 79600-001

NDC 79600-001-01

Package Description: 50 SWAB in 1 PACKAGE

NDC 79600-001-02

Package Description: 60 SWAB in 1 BOTTLE

NDC Product Information

Disinfectant Wipes with NDC 79600-001 is a a human over the counter drug product labeled by Guangzhou Dicallo Co.,ltd. The generic name of Disinfectant Wipes is disinfectant wipes. The product's dosage form is swab and is administered via topical form.

Labeler Name: Guangzhou Dicallo Co.,ltd

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Disinfectant 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 1/1001

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)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Guangzhou Dicallo Co.,ltd
Labeler Code: 79600
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: 07-17-2020 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.

Disinfectant Wipes Product Label Images

Disinfectant 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

Use one wipe per object to avoid cross contamination.Seal after each use.Avoid direct contact with eyes, if so flush with plenty if water for 15 minutes immediately.Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive Ingredient

Gylcerin, Hydrogen Proxide, Ro Pure Water

Otc - Active Ingredient

Ethyl Alcohol 75%…………Antimicriobial

Warnings

For external use only. Flammable. Keep away from flame.

Otc - Ask Doctor

Stop the use and ask a doctor if irritation or rash occurs. These may signs if serious conditions.

Otc - Keep Out Of Reach Of Children

If swalloerd, get medical help or contact a Poison Control Center right away.

Otc - Do Not Use

  • Do not usein child less than 2 months of age.on open skin wounds.

Otc - When Using

When using this product, keep out od eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Indications & Usage

Helps reduce bacteria on the skin.

Otc - Purpose

Helpa reduce bacrteria on the skin.

* Please review the disclaimer below.