NDC 75158-007 Germ Shark Px3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol

Isopropyl Alcohol

NDC Product Code 75158-007

NDC CODE: 75158-007

Proprietary Name: Germ Shark Px3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Isopropyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 75158 - Germ Shark, Llc
    • 75158-007 - Germ Shark Px3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol

NDC 75158-007-01

Package Description: 105 PATCH in 1 CANISTER > 4 mL in 1 PATCH

NDC Product Information

Germ Shark Px3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol with NDC 75158-007 is a a human over the counter drug product labeled by Germ Shark, Llc. The generic name of Germ Shark Px3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol is isopropyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Germ Shark, 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.

Germ Shark Px3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol 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 .7 mL/mL

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)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

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.
  • 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: Germ Shark, Llc
Labeler Code: 75158
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: 10-21-2020 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.

Germ Shark Px3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol Product Label Images

Germ Shark Px3 Thick Premium Disinfecting Alcohol Hand Wipes 70 Isopropyl Alcohol 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 Ingredients

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

Inactive Ingredients

  • Water, Benzalkonium Chloride, Cetylpyridinium Chloride* Wipe fabric is made of polyester and rayonGerm Shark is registered with the FDA in the United States.

Uses

  • Hand wipes to help reduce bacteria that can potentially cause sickness and disease. For use when soap & water are not available.Intended for use on hands, arms and legs

Warnings

For external use only. Flammable. Keep away from heat or flame. Use in a well-ventilated area and avoid using near sources of ignition.

Do Not Use

  • On children under 2 months of age - supervise all use by children on open skin wounds - keep out of reach of children and petsfor a personal hygiene or as a make-up removing or baby wipe

Keep Out Of Reach Of Children

If eaten, swallowed or chewed get medical help or contact a Poison Control center right away (Poison Control in USA: 1-800-222-1222)

When Using This Product

  • Avoid contact with eyes and damaged skin, If contact, occurs, rinse thoroughly in running water.

Stop Use And Ask A Doctor

If irritation, redness or rash occurs for over 72 hours, These may be signs of a serious condition.

Other Information

  • Avoid freezing and excessive heat above 40C (104F)Store between 15-30C (59-86F)Keep away from direct sunlight, heat and flames

How To Use:

Peel back top cover and remove protective film to access the wipes. Locate the wipe at the center of the roll and insert its corner through the opening of the cap. Do NOT push your fingers through the opening. Replace the cover and snap lid securely shut. Pull each wipe with a little force. To keep wipes fresh and moist, close lid after use.Wipe your hands thoroughly and let dry. Let hands completely dry before coming in close contact with any open flame.For best results, clean excessively dirty areas before using wipes.Please do not flush these wipes. We recommend that you dispose of them in the trash. Flushing wipes can cause damaged in plumbing.

* Please review the disclaimer below.