NDC 81737-001 Sanitizetek Gel

Isopropyl Alcohol

NDC Product Code 81737-001

NDC 81737-001-01

Package Description: .059 L in 1 BOTTLE, DISPENSING

NDC 81737-001-02

Package Description: .5 L in 1 BOTTLE, PUMP

NDC 81737-001-04

Package Description: 3.7 L in 1 BOTTLE, PLASTIC

NDC 81737-001-05

Package Description: 208 L in 1 DRUM

NDC 81737-001-06

Package Description: 6705 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

NDC Product Information

Sanitizetek Gel with NDC 81737-001 is a a human over the counter drug product labeled by Sanitizetek, Llc. The generic name of Sanitizetek Gel is isopropyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Sanitizetek, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Sanitizetek Gel 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 .7 L/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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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: Sanitizetek, Llc
Labeler Code: 81737
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: 03-22-2021 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.

Sanitizetek Gel 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

Other

Drug Facts

Otc - Active Ingredient

Active IngredientIsopropyl Alcohol, 70%

Otc - Purpose

PurposeAntiseptic

Indications & Usage

Uses♦ Hand sanitizer to help reduce bacteria on the skin that could cause disease♦ Recommended for repeated use

Warnings

Warnings: Flammable. Keep away from fire or flame.For external use onlyWhen using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or rash appears and persists

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions♦ Place enough product in your palm to thoroughly cover hands.♦ Rub hands together briskly until dry.♦ Children under 6 years of age should be supervised when using this product.

Other Safety Information

Other information♦ Store between 59-86º F (15 - 30° C)♦ Avoid freezing and excessive heat above 110º F (43º C)

Inactive Ingredient

Inactive Ingredients: Aloe Barbadensis Gel, Alpha-Tocopheryl Acetate (Vitamin-E), Carbomer, Diisopropanolamine, Glycerin, Purified Water

Package Label

SanitizeTekThe Front Line in Sanitizer and Disinfectant InnovationHand Sanitizer Gel70% Isopropyl AlcoholAlorSoothes & Nourishes Skin withAloe Vera & Vitamin EEthanol Free, Safe for Repeated Use2 fl oz (59 mL)www.sanitizeTek.com (888) 7000-TEKPacked by: SanitizeTek, LLC109C Shooting Club Rd., Boerne, TX 780062 OZ16.9 OZ1 GAL55 GAL330 GALres

* Please review the disclaimer below.