NDC 72920-2001 Plane It Safe Hand Sanitizer

Hand Sanitizer

NDC Product Code 72920-2001

NDC 72920-2001-2

Package Description: 59 mL in 1 BOTTLE

NDC Product Information

Plane It Safe Hand Sanitizer with NDC 72920-2001 is a a human over the counter drug product labeled by Plane It Safe Llc. The generic name of Plane It Safe Hand Sanitizer is hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Plane It Safe 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.

Plane It Safe 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.

  • ALCOHOL 62 mL/100mL

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Plane It Safe Llc
Labeler Code: 72920
FDA Application Number: part333E 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: 03-26-2019 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: 12-31-2020 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.

Plane It Safe 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

Warnings: For External Use Only

Warnings: FOR EXTERNAL USE ONLYFlammable- Keep away from heat and flames.When using this product do NOT use in or around the eye. In case of contact, flush eyes with water thoroughlyKeep out of the reach of children. Do not ingest- If swallowed get medical help or contact a poison control center immediately.STOP and ask a physician if irratition, redness or rash develop and persist for longer than 72 hours.Directions:-Thoroughly apply product on hands & rub together until dry.-Adult supervision recommended for anyone 6 years of age & under.Do not store above 105F-May discolor some fabrics or finishes-Harmful to wood finishes and plastics

Active Ingreditents

Ethyl Alcohol 62%

Keep Out Of The Reach Of Children

Keep out of the reach of children. Do not ingest and if swollowed get help or contact a poison control center immediately.

Stop Use

Stop use and contact a physician if irratitation redness or rash occur

Purpose

Purpose Antiseptic

Directions:

Directions: Thoroughly apply the product on your hands and rub together until dry

Inactive Section

Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance,Lactose,Microcrystalline Cellulose,Sucrose,Zea Mays(Corn) Starch,Tocopheryl Acetate,Hydroxypropyl Methylcellulose,Ultamarines(CI77007)­­­­­­­­­­­­­­

Uses

Hand sanitizer to decrease bacteria on the skin

* Please review the disclaimer below.

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