NDC 69243-1112 Microbe Bloc Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 69243-1112

NDC 69243-1112-1

Package Description: 44 mL in 1 BOTTLE, PUMP

NDC 69243-1112-2

Package Description: 59 mL in 1 BOTTLE, PUMP

NDC 69243-1112-3

Package Description: 118 mL in 1 BOTTLE, PUMP

NDC 69243-1112-4

Package Description: 237 mL in 1 BOTTLE, PUMP

NDC 69243-1112-5

Package Description: 473 mL in 1 BOTTLE, PUMP

NDC 69243-1112-6

Package Description: 946 mL in 1 BOTTLE, PUMP

NDC 69243-1112-7

Package Description: 3785 mL in 1 BOTTLE, PUMP

NDC Product Information

Microbe Bloc Hand Sanitizer with NDC 69243-1112 is a a human over the counter drug product labeled by Willspeed Technologies Llc. The generic name of Microbe Bloc Hand Sanitizer is benzalkonium chloride. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Willspeed Technologies Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Microbe Bloc Hand Sanitizer 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 .0013 g/mL

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)
  • AVENA SATIVA LEAF (UNII: 206PI19V7R)
  • BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SOY PROTEIN (UNII: R44IWB3RN5)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • JOJOBA OIL (UNII: 724GKU717M)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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: Willspeed Technologies Llc
Labeler Code: 69243
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: 03-01-2021 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: 12-31-2022 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 - NO 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.

Microbe Bloc Hand Sanitizer 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

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

Hand sanitizing and to decrease bacteria on the skin.

Warnings

For external use only.

Do Not Use In The Eyes.

In case of eye contact, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

If irritation or redness develops, or if condition persists more than 72 hours.

Keep Out Of Reach Of Children.

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a small amount to hands and rub until dry. Lotion does not replace soap and water.

Inactive Ingredients

Aloe Barbadensis Extract, Avena Sativa (Oat) Extract, Behentrimonium Methosulfate, Caprylyl Glycol, Cetearyl Alcohol, Cetrimonium Chloride, Dimethicone, Glycerin, Hydrolyzed Soy Protein, Mentha Piperita (Peppermint) Essential Oil, Phenoxyethanol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Vitamin A Palmitate, Vitamin E Acetate, Water.

* Please review the disclaimer below.