NDC 39892-0412 Antiseptic Hand Rub

Alcohol

NDC Product Code 39892-0412

NDC 39892-0412-1

Package Description: 1.5 mL in 1 PACKET

NDC Product Information

Antiseptic Hand Rub with NDC 39892-0412 is a a human over the counter drug product labeled by Owens & Minor Distribution, Inc.. The generic name of Antiseptic Hand Rub 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 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 Rub 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 620 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)
  • DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)
  • LEMON (UNII: 24RS0A988O)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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.

Product Labeler Information

What 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 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: 03-01-2019 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: 12-31-2020 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 Rub Product Label Images

Antiseptic Hand Rub 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 denat. (anhydrous) 62%

Purpose

Antiseptic

Use

Instant hand antiseptic

Warnings

For external use only. Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.


Flammable. Keep away from fire or flame.

Stop Use And Ask A Doctor

If significant irritation or sensitization occurs.

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions

  • Apply to clean, dry handsWet hands thoroughly with product and allow to dry

Other Information

  • Recommended for repeated use Reduces bacteria that can potentially cause disease

Inactive Ingredients

Purified water, Carbomer 2020, PPG-20 methyl glucose ether, Carbomer 980, Diisopropanolamine, Fragrance (Lemon), FD&C blue No.1, FD&C yellow No.5

* Please review the disclaimer below.

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