NDC 39892-0401 Medichoice Instant Hand Sanitizer Fragrance Free

Alcohol

NDC Product Code 39892-0401

NDC Code: 39892-0401

Proprietary Name: Medichoice Instant Hand Sanitizer Fragrance Free Additional informationCallout TooltipWhat 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: Alcohol Additional informationCallout TooltipWhat 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.


Code Structure
  • 39892 - Owens & Minor Distribution, Inc.
    • 39892-0401 - Medichoice Instant Hand Sanitizer

NDC 39892-0401-2

Package Description: 118 mL in 1 BOTTLE

NDC 39892-0401-3

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Medichoice Instant Hand Sanitizer Fragrance Free with NDC 39892-0401 is a a human over the counter drug product labeled by Owens & Minor Distribution, Inc.. The generic name of Medichoice Instant Hand Sanitizer Fragrance Free is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Owens & Minor Distribution, 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 Additional informationCallout TooltipWhat 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.


Medichoice Instant Hand Sanitizer Fragrance Free Active Ingredient(s)

Additional informationCallout TooltipWhat 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 700 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Administration Route(s)

Additional informationCallout TooltipWhat 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.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Owens & Minor Distribution, Inc.
Labeler Code: 39892
FDA Application Number: part333E Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-21-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Medichoice Instant Hand Sanitizer Fragrance Free Product Label Images

Medichoice Instant Hand Sanitizer Fragrance Free 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

Purpose

Antiseptic

Uses

  • Hand sanitizer to help reduce bacteria
  • On the skin

Warnings

Flammable. Keep away from fire or flameFor external use only - hands.

Do Not Use

In or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop Use And Ask A Doctor

If skin irritation and redness or rash develops.

Keep Out Of Reach Of Children.

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

Directions

  • Place enough product in your palm to thoroughly cover your handsrub hands together briskly until drychildren under 6 years of age should be supervised when using this productnot recommended for infants

Other Information

  • Store at normal room temperature may discolor certain fabricsmay be harmful to wood finishes and plastics

Inactive Ingredients

Purified Water, Isopropyl Alcohol, Propylene Glycol, Aloe Barbadensis Leaf Juice (Decolorized), Carbomer, Glycerin, Aminomethyl Propanol, Isopropyl Myristate, Tocopheryl Acetate

* Please review the disclaimer below.

Previous Code
39892-0400
Next Code
39892-0412