NDC 78536-002 Disinfection Wet Wipes

Alcohol

NDC Product Code 78536-002

NDC 78536-002-01

Package Description: 2000 BAG in 1 CARTON > 1 POUCH in 1 BAG > 5 mL in 1 POUCH

NDC 78536-002-02

Package Description: 200 BAG in 1 CARTON > 10 POUCH in 1 BAG > 54 mL in 1 POUCH

NDC 78536-002-03

Package Description: 30 BAG in 1 CARTON > 50 POUCH in 1 BAG > 270 mL in 1 POUCH

NDC 78536-002-04

Package Description: 30 BAG in 1 CARTON > 60 POUCH in 1 BAG > 324 mL in 1 POUCH

NDC 78536-002-05

Package Description: 24 BAG in 1 CARTON > 70 POUCH in 1 BAG > 378 mL in 1 POUCH

NDC 78536-002-06

Package Description: 24 BAG in 1 CARTON > 90 POUCH in 1 BAG > 486 mL in 1 POUCH

NDC 78536-002-07

Package Description: 24 BAG in 1 CARTON > 100 POUCH in 1 BAG > 540 mL in 1 POUCH

NDC 78536-002-08

Package Description: 24 BAG in 1 CARTON > 120 POUCH in 1 BAG > 648 mL in 1 POUCH

NDC 78536-002-09

Package Description: 12 BAG in 1 CARTON > 200 POUCH in 1 BAG > 1080 mL in 1 POUCH

NDC 78536-002-10

Package Description: 40 BOTTLE in 1 CARTON > 60 POUCH in 1 BOTTLE > 324 mL in 1 POUCH

NDC Product Information

Disinfection Wet Wipes with NDC 78536-002 is a a human over the counter drug product labeled by Zhejiang Yiwu Mingou Biotechnology Co., Ltd.. The generic name of Disinfection Wet Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Zhejiang Yiwu Mingou Biotechnology 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.

Disinfection Wet 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.

  • 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: Zhejiang Yiwu Mingou Biotechnology Co., Ltd.
Labeler Code: 78536
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: 07-07-2020 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.

Disinfection Wet Wipes Product Label Images

Disinfection Wet 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

Use

Use: Health care personnel hand rub to help

reduce bacteria that potentially can cause disease.

Warning

For external use only. Flammable.

Keep away from heat or flame.

Do not use

●in children less than 2 months of age

●on open skin wounds

When using this product

●keep out of eyes, ears, and mouth.

●if case of contact with eyes, rinse

eyes thoroughly with water

Stop use and ask a doctor if

●irritation and redness develop. These

may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact

a Poison Control Center right away

Directions

Directions●Place enough product on

hands to cover all surfaces. Rub hands

together until dry.

●Supervise children under 6 years of age

when using this product to avoid swallowing.

Inactive Ingredients

25% Pure Water

* Please review the disclaimer below.