NDC 76250-134 Problend Alcohol Hand Sanitizer Gel

Isopropyl Alcohol

NDC Product Code 76250-134

NDC 76250-134-01

Package Description: 3785 mL in 1 BOTTLE

NDC 76250-134-08

Package Description: 237 mL in 1 BOTTLE

NDC 76250-134-16

Package Description: 473 mL in 1 BOTTLE

NDC 76250-134-33

Package Description: 1249000 mL in 1 CONTAINER

NDC Product Information

Problend Alcohol Hand Sanitizer Gel with NDC 76250-134 is a a human over the counter drug product labeled by Seatex, Llc. The generic name of Problend Alcohol Hand Sanitizer Gel is isopropyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Seatex, 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.

Problend Alcohol Hand Sanitizer 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.

  • ISOPROPYL ALCOHOL 64 mL/64mL

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)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • RAPIDGEL EZ1 (UNII: 33JH4A7R2K)

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: Seatex, Llc
Labeler Code: 76250
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: 12-21-2020 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.

Problend Alcohol Hand Sanitizer 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

Otc - Active Ingredient

Active Ingredient PurposeIsopropyl Alcohol 70% v/v..........Antiseptic

Otc - Purpose

Antiseptic, Hand Sanitizer

Indications & Usage

UsesFor hand sanitizing to decrease bacteria on the skin.

Warnings

Warnings For external use only. Flammable. Keep away from heat or flame.

Otc - When Using

When using this product Avoid contact with
eyes. In case of eye contact, flush eyes with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rednessdevelops and conditions persist for more than72 hours.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

DirectionsPlace enough product in your palm tothoroughly cover handsRub hands together briskly until dry.Children under 6 years of age shoud besupervised when using this product.

Inactive Ingredient

Inactive IngredientsPolyacrylic Acid, Water, Dye

* Please review the disclaimer below.