NDC 72762-005 Antiseptic Hand Sanitizer Citrus Scent

Alcohol

NDC Product Code 72762-005

NDC 72762-005-16

Package Description: 1 BOTTLE, SPRAY in 1 BLISTER PACK > 15 mL in 1 BOTTLE, SPRAY (72762-005-15)

NDC Product Information

Antiseptic Hand Sanitizer Citrus Scent with NDC 72762-005 is a a human over the counter drug product labeled by Two's Company, Inc.. The generic name of Antiseptic Hand Sanitizer Citrus Scent is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Two's Company, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Antiseptic Hand Sanitizer Citrus Scent 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 .62 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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.
  • 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: Two's Company, Inc.
Labeler Code: 72762
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: 10-01-2020 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.

Antiseptic Hand Sanitizer Citrus Scent Product Label Images

Antiseptic Hand Sanitizer Citrus Scent 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 62%

Purpose

Antimicrobial

Indications & Usage

Uses ■ helps to reduce bacteria on the skin        ■ recommended for repeated use

Warnings

For external use only.Flammable: Keep away from heat and flamewhen using this product ■ do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water ■ do not apply to irritated or broken skin.Stop use and ask a doctor if ■ irritation and redness develop ■ condition persists for more than 72 hours.

Otc - 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.

Directions

■ lift tab and spray a small amount into the palms of your hands and forearms.■ wet the hands thoroughly with product, rub hands together and allow to dry without wiping ■ no rinsing required.■ children under 6 years of age should be supervised when using this product ■ not recommended for infants.

Storage And Handling

Other information ■ do not store above 105°F                                 ■ may discolor some fabrics or surfaces.

Inactive Ingredients

Fragrance, Glycerin, Propylene Glycol, Water

* Please review the disclaimer below.