NDC 77046-006 Hand Sanitizing Wipes

Wipe

NDC Product Code 77046-006

NDC 77046-006-01

Package Description: 45 PATCH in 1 BOX > 4.2 g in 1 PATCH

NDC Product Information

Hand Sanitizing Wipes with NDC 77046-006 is a a human over the counter drug product labeled by Zhejiang Huashun Technology Co.,ltd. The generic name of Hand Sanitizing Wipes is wipe. The product's dosage form is patch and is administered via topical form.

Labeler Name: Zhejiang Huashun Technology Co.,ltd

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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 Sanitizing 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.

  • BENZALKONIUM CHLORIDE .0042 g/4.2g

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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE (UNII: V5VD430YW9)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)

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 Huashun Technology Co.,ltd
Labeler Code: 77046
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: 07-13-2020 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.

Hand Sanitizing Wipes Product Label Images

Hand Sanitizing 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

Active Ingredient(S)

Benzalkonium chloride 0.1%. Purpose: Antiseptic

Purpose

Antiseptic

Use

Instant healthcare personnnel hand antiseptic to reduce bacteria that potentially can cause diseaseinstant hand antiseptic to decrease bacteria on the skin

Warnings

For external use only.

Do Not Use

In combination with soap or antibacterial cleansing agentsthe product for a long time in the same area as swelling,inflammation or sickness may occur due to absorption through the skin

Otc - When Using

Avoid using repeatedly in the same area,skin irritation may occuravoid getting into the eyes(if contact occurs,wash well with clean water)if following abnormal symptoms persist,discontinue use,irritation around the eyes ears,mucous membranes,including the mouth,under the skin irritation and rashes

Otc - Stop Use

Hypersensitivity symotoms such as erythema,itching and dermatitis happenskin irritation happens

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222)right away.

Directions

Read the direction and warnings before useavoid freezing and excessive heat above 40℃(104℉)

Inactive Ingredients

Water,phenoxyethanol,glycerin,sodium benzoate,polysibate 20,Disodium EDTA ,tocopheryl acetate,acid

* Please review the disclaimer below.