NDC 70108-019 Minions Antibacterial Hand Wipes

Benzalkonium Chloride

NDC Product Code 70108-019

NDC 70108-019-01

Package Description: 25 PACKAGE in 1 PACKET > .004 g in 1 PACKAGE

NDC Product Information

Minions Antibacterial Hand Wipes with NDC 70108-019 is a a human over the counter drug product labeled by Ashtel Studios, Inc.. The generic name of Minions Antibacterial Hand Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Ashtel Studios, Inc.

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.

Minions Antibacterial 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 .1 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.

  • BRONOPOL (UNII: 6PU1E16C9W)
  • ALCOHOL (UNII: 3K9958V90M)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ashtel Studios, Inc.
Labeler Code: 70108
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: 08-26-2019 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: 12-31-2020 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.

Minions Antibacterial Hand Wipes Product Label Images

Minions Antibacterial 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 Ingredients

Benzalkonium chloride 0.1%

Purpose

Antibacterial

Use

Decrease bacteria on skin.

Warnings

For external use only.Do not use over large area of the body if you are allergic to any of the ingredients.When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

Keep Out Of Reach Of Children.

If swallowed, seek medical attention or contact a Poison Control Center right away.

Directions

  • For adults and children of 3 years and over, use on hands to clean and refresh, allow skin to air dry.For children under 3 years of age, consult with a doctor before use.

Inactive Ingredients

2-Bromo-2-Nitropropane-1, 3-Diol, Alcohol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Fragrance, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Water.

* Please review the disclaimer below.