NDC 78043-250 Sanitizer

Zero Hazard

NDC Product Code 78043-250

NDC 78043-250-01

Package Description: 3.785 L in 1 BOTTLE

NDC 78043-250-02

Package Description: 18.9271 L in 1 PAIL

NDC 78043-250-03

Package Description: 113.562 L in 1 DRUM

NDC 78043-250-04

Package Description: 208.198 L in 1 DRUM

NDC 78043-250-05

Package Description: 1022.06 L in 1 DRUM

NDC Product Information

Sanitizer with NDC 78043-250 is a a human over the counter drug product labeled by Holy Water Solutions, Llc. The generic name of Sanitizer is zero hazard. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Holy Water Solutions, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

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.

  • HYPOCHLOROUS ACID 250 mg/L

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: Holy Water Solutions, Llc
Labeler Code: 78043
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-25-2020 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.

Sanitizer Product Label Images

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

Directions

Apply to sanitize any hard surface quickly and effectively. Thouroughly cover the surface with sanitizing solution. If the surface needs to be dried, wait 15 seconds, then wipe dry. May be diluted 5:1.

Warnings

Keep out of reach of children

Keep out of reach of children

Uses:

  • Washing and peeling fruits and vegetables
  • Acid-modification in food starchIndirect food additivesSanitizing solution for food contact surfaces and articles - approved substance utilized to control the growth of Microorganisms (CFR 2 Sec 178.1010) for food contact surfaces, processing equipment, utencils, and hard non-porous surfacesHospitals, restaurants, food processing, factory, stadium, schools, fleet services, transportation vehicles, office space

Storage And Handling

Keep out of direct sunlight and do not freeze. No special handling or disposal precautions. Biodegradable and environmentally safe.

Inactive Ingredients

Water 99.98%

Other Information

At a pH of 6.0-7.5 (neutral), EW (ORP=750mV) contains primarily hypochlorous acid, hypochlorite ion and trace amounts of chlorine. The effectiveness of neutral EW as a sanitizer has been demonstrated for reducing Escherichia coli O157:H7, Salmonella enteritidis and Listeria monocytogenes biofilms on the surface of tomato (Deza et al., 2003) and also on plastic and wooden cutting boards (Deza et al., 2007)Deza, M.A., Araujo, M. and Garrido, M.J. (2003) Inactivation of Escherichia coli O157:H7, Salmonella enteritidis and Listeria monocytogenes on the surface of tomatoes by neutral electrolyzed water, Letters of Applied Microbiology, 37, pp. 482-487.Deza, M.A., Araujo, M. and Garrido, M.J. (2007) Efficacy of neutral electrolyzed water to inactivate Escherichia coli, Listeria monocytogenes, Pseudomonas aeruginosa and Staphyloccoccus aureus on plastic and wooden kitchen cutting boards, Journal of Food Protection, 70:1, pp. 102-108

Purpose

Sanitizing & Deodorizing

Active Ingredient

Hypochlourous Acid 0.025%

* Please review the disclaimer below.