NDC 77070-701 Antimicrobial Hand Wipes

Antimicrobial Hand Wipes

NDC Product Code 77070-701

NDC 77070-701-20

Package Description: 1 g in 1 POUCH

NDC Product Information

Antimicrobial Hand Wipes with NDC 77070-701 is a a human over the counter drug product labeled by Goodfibers. The generic name of Antimicrobial Hand Wipes is antimicrobial hand wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Goodfibers

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.

Antimicrobial Hand 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 .125 g/100g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • WATER (UNII: 059QF0KO0R)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

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: Goodfibers
Labeler Code: 77070
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: 07-11-2020 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.

Antimicrobial Hand Wipes Product Label Images

Antimicrobial Hand 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

Active IngredientBenzalkonium Chloride 0.125%

Purpose

PuposeAntimicrobial

Uses

Uses* For hand washing to decrease bacteria on skin without requiring water or rinsing* Recommended for repeated use

Warnings

WarningsFor external use only

When Using This Product

When using this product* Do not use in or near eyesIf contact occurs, rinse eyes thoroughly with water

Stop Use And Ask A Doctor

Stop use and ask a doctor*If irritation and redness persist for more than 72 hours

Keep Out Of Reach Of Children

Keep out of reach of childrenIn case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

Directions* Wet thoroughly hands with wipe and allow to dry without wiping.* Children under six years of age should be supervised when using this product

Inactive Ingredients

Inactive IngredientsAloe Barbadensis Leaf Juice, Citric Acid, Decyl Glucoside, Fragrance, Phenoxyethanol, Potassium Sorbate, Tetrasodium EDTA, Water.

* Please review the disclaimer below.