NDC 80862-001 Germisept 70 Isopropyl Rubbing Alcohol Wipes

Isopropyl Alcohol

NDC Product Code 80862-001

NDC 80862-001-01

Package Description: 50 PATCH in 1 POUCH > 4.32 mL in 1 PATCH

NDC 80862-001-02

Package Description: 150 PATCH in 1 CANISTER > 4.73 mL in 1 PATCH

NDC Product Information

Germisept 70 Isopropyl Rubbing Alcohol Wipes with NDC 80862-001 is a a human over the counter drug product labeled by Alpha Hygiene Llc. The generic name of Germisept 70 Isopropyl Rubbing Alcohol Wipes is isopropyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Alpha Hygiene Llc

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Germisept 70 Isopropyl Rubbing Alcohol Wipes 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: Alpha Hygiene Llc
Labeler Code: 80862
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: 01-26-2021 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 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.

Germisept 70 Isopropyl Rubbing Alcohol Wipes Product Label Images

Germisept 70 Isopropyl Rubbing Alcohol Wipes 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

Isopropyl Alcohol 70% (v/v)


First aid antiseptic


First Aid to help prevent the risk of infection in minor cuts, scrapes, and burns


FLAMMABLE. Keep away from fire or flame, heat, and spark. For external use only. Consult a doctor before use if you have a deep or puncture wounds, animal bites, serious burns.

When Using This Product

Do not get in eyes. Do not apply over large areas.

Do Not Use

Longer than one week unless directed by a doctor.

Stop Use And Ask Doctor

If condition persists or gets wrose.

Keep Out Of Reach Of Children.

If swallowed get medical help or contact a Poison Control Center right away.


  • Clean the affected areaapply product on affected area of the body 1 to 3 times a daymay be covered with a steriled bandage If bandaged let dry first.

Other Information

  • Do not apply internally.Keep the lid closed to retain the moisture of the wipes.Hold the pack away from the face while opening.Keep in room temperature.Do not flush down the toilet.

Inactive Ingredients:

Aqua (Purified & De-Ionized Water).

* Please review the disclaimer below.