NDC 81627-025 Bioshield 99 Alcohol

Sanitizer

NDC Product Code 81627-025

NDC 81627-025-02

Package Description: 60 mL in 1 BOTTLE, SPRAY

NDC 81627-025-10

Package Description: 300 mL in 1 BOTTLE, SPRAY

NDC 81627-025-32

Package Description: 1000 mL in 1 BOTTLE, SPRAY

NDC 81627-025-50

Package Description: 3785 mL in 1 BOTTLE, SPRAY

NDC Product Information

Bioshield 99 Alcohol with NDC 81627-025 is a a human over the counter drug product labeled by Naturally Safe Solutions, Llc. The generic name of Bioshield 99 Alcohol is sanitizer. The product's dosage form is spray and is administered via topical form.

Labeler Name: Naturally Safe Solutions, Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Bioshield 99 Alcohol 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.

  • ALCOHOL 800 mL/1000mL

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.

  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • WATER (UNII: 059QF0KO0R)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)

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: Naturally Safe Solutions, Llc
Labeler Code: 81627
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: 03-04-2021 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Bioshield 99 Alcohol 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

Dosage & Administration

Product NDC: 81311-025:Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry.




Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive Ingredient

Product NDC: 81311-025:HYDROGEN PEROXIDE, GLYCERIN, CINNAMON OIL, ANHYDROUS CITRIC ACID, WATER

Indications & Usage

Product NDC: 81311-025:Use(s): Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Otc - Keep Out Of Reach Of Children

Product NDC: 81311-025: If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Otc - Purpose

Product NDC: 81311-025: Antiseptic

Otc - Active Ingredient

Product NDC: 81311-025: Alcohol 80% v/v

Warnings

Product NDC: 81311-025: For external use only. Flammable. Keep away from heat or flame

Otc - Do Not Use

Product NDC: 81311-025: in children less than 2 months of age • on open skin wounds

Otc - When Using

Product NDC: 81311-025: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Otc - Stop Use

Product NDC: 81311-025: if irritation or rash occurs. These may be signs of a serious condition.

Other Safety Information

Product NDC: 81311-025: Store between 15-30C (59-86F)• Avoid freezing and excessive heat above 40C (104F)

* Please review the disclaimer below.