NDC 45942-1001 Giovanni - Antibacterial Hand Sanitizer - Fragrance Free 70 Percent

Ethyl Alcohol

NDC Product Code 45942-1001

NDC CODE: 45942-1001

Proprietary Name: Giovanni - Antibacterial Hand Sanitizer - Fragrance Free 70 Percent 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: Ethyl 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

NDC 45942-1001-2

Package Description: 59 mL in 1 BOTTLE

NDC 45942-1001-7

Package Description: 710 mL in 1 BOTTLE

NDC 45942-1001-8

Package Description: 250 mL in 1 BOTTLE

NDC Product Information

Giovanni - Antibacterial Hand Sanitizer - Fragrance Free 70 Percent with NDC 45942-1001 is a a human over the counter drug product labeled by Giovanni Cosmetics, Inc.. The generic name of Giovanni - Antibacterial Hand Sanitizer - Fragrance Free 70 Percent is ethyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Giovanni Cosmetics, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Giovanni - Antibacterial Hand Sanitizer - Fragrance Free 70 Percent 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 70 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)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

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: Giovanni Cosmetics, Inc.
Labeler Code: 45942
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: 05-05-2020 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.

Giovanni - Antibacterial Hand Sanitizer - Fragrance Free 70 Percent Product Label Images

Giovanni - Antibacterial Hand Sanitizer - Fragrance Free 70 Percent 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

ETHYL ALCOHOL 70%

Purpose

ANTIMICROBIAL

Uses

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE OR ILLNESS.

Warnings

  • For external use only: handsFlammable. Keep away from heat or flame.Do not use:On children less than 2 months of ageOn open skin woundsAvoid contact with eyes, rinse eyes thoroughly with water. If swallowed, get medical help or contact a poison control center right away.Stop use and ask a doctor if irritation, rash or redness develops. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

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

Directions

Distribute enough product onto palms of hands to cover hands completely, and rub hands together until dry. Adult supervision should occur for children using this product who are under 6 years of age to avoid swallowing.

Other Information:

  • Store between 15° - 30°C (59° - 86°F)Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients:

ALCOHOL DENAT., AQUA (PURIFIED WATER), TOCOPHEROL ACETATE (VITAMIN E), *ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, *CHAMOMILE RECUTITA (MATRICARIA) FLOWER EXTRACT, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL*USDA CERTIFIED ORGANIC

Questions?

1-800-563-5468 (MONDAY THRU FRIDAY, 8:00AM - 5:00PM PST)

* Please review the disclaimer below.