NDC 60742-400 One Step

Hand Sanitizer

NDC Product Code 60742-400

NDC 60742-400-01

Package Description: 60 mL in 1 BOTTLE

NDC 60742-400-03

Package Description: 473 mL in 1 BOTTLE, PUMP

NDC 60742-400-04

Package Description: 236 mL in 1 BOTTLE, PUMP

NDC Product Information

One Step with NDC 60742-400 is a a human over the counter drug product labeled by Belvedere International Inc.. The generic name of One Step is hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Belvedere International Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

One Step 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.

  • EDETOL (UNII: Q4R969U9FR)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
  • 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: Belvedere International Inc.
Labeler Code: 60742
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: 02-03-2020 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.

One Step 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%v/v .........Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from source of heat, fire or flame.For external use only.

Otc - Stop Use

Stop use and ask a doctor if irritation or redness develops and lasts.

Otc - When Using

When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Place enough product in your palm to thoroughly cover your hands and rub hands together until dry.Children under 6 years should be supervised when using this product.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Ext. Violet 2 (CI 60730), Fragrance (Parfum), Polysorbate 20, Tetrahydroxypropyl Ethylenediamine, Water (Aqua).

Other Safety Information

Store at a temperature below 110 F (43
oC)
may discolor certain fabrics or surfaces.

Dosage & Administration

Children under 6 years should be supervised when using this product

* Please review the disclaimer below.