NDC 69345-300 Altitude Medical Hand Sanitizer

Ethyl Alcohol, 70%

NDC Product Code 69345-300

NDC 69345-300-01

Package Description: 408 mL in 1 CARTRIDGE

NDC Product Information

Altitude Medical Hand Sanitizer with NDC 69345-300 is a a human over the counter drug product labeled by Altitude Medical. The generic name of Altitude Medical Hand Sanitizer is ethyl alcohol, 70%. The product's dosage form is gel, metered and is administered via topical form.

Dosage Form: Gel, Metered - A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.

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.

Altitude Medical 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.

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: Altitude Medical
Labeler Code: 69345
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: 11-01-2021 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.

Altitude Medical 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

Active Ingredient

ACTIVE INGREDIENTEthyl alcohol …….. 70% v/v




Hand sanitizer to help reduce bacteria on the skin


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

When Using

When using this product do not use in or near eyes.In case of contact, rinse eyes thoroughly with water.

Stop Use

Stop use and ask a doctor if irritation or rash occurs and lasts.

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.


• Place enough product in your palm to cover hands and rub hands together briskly until dry.• Children under 6 years of age should be supervised when using this product.

Other Information

• Store below 100°F (43°C)• May discolor certain fabrics or surfaces.

Inactive Ingredients

Glycerin, isopropyl alcohol, PEG-6 (and) AMP-acrylates/vinyl isodecanoate crosspolymer, purified water

* Please review the disclaimer below.