NDC 77578-003 Sanitizer

Alcohol, Citric Acid

NDC Product Code 77578-003

NDC 77578-003-01

Package Description: 500 mL in 1 BOTTLE

NDC 77578-003-02

Package Description: 1000000 mL in 1 CONTAINER

NDC Product Information

Sanitizer with NDC 77578-003 is a a human over the counter drug product labeled by Nutraze, S.c De R.l. De C.v.. The generic name of Sanitizer is alcohol, citric acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Nutraze, S.c De R.l. De C.v.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

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 80 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.

  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Nutraze, S.c De R.l. De C.v.
Labeler Code: 77578
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: 07-16-2020 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.

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

Alcohol 80% Purpose: Antiseptic

Inactive Ingredients

Glycerin, hydrogen peroxide, purifed water.

Use(S)

Hand Sanitizer Antiseptic solution to help reduce bateria that potentially can cause disease. For use when soap and water are not available.

Warnings

Flammable. Keep away from heat or flame.

Otc - Do Not Use

- In children less than 2 months of age- In open skin wounds

Otc - When Using

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Otc - Purpose

Antiseptic

Otc - Stop Use

If irritation or rash occurs. These may be signs of a serious condition.

Otc - Ask Doctor

If irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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

Other Information

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

Other

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

2. Glycerol (1.45% v/v).

3. Hydrogen peroxide (0.125% v/v).

4. Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Dosage & Administration

Topical

* Please review the disclaimer below.