NDC 62569-000 Genlabs Strike Bac Antibacterial Handsoap

Chloroxylenol Soap Topical

NDC Product Information

Genlabs Strike Bac Antibacterial Handsoap with NDC 62569-000 is a human over the counter drug product labeled by Genlabs Corporation. The generic name of Genlabs Strike Bac Antibacterial Handsoap is chloroxylenol. The product's dosage form is soap and is administered via topical form.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Genlabs Strike Bac Antibacterial Handsoap 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.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:

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.

  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Genlabs Corporation
Labeler Code: 62569
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: 08-29-2013 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Genlabs Strike Bac Antibacterial Handsoap Product Label Images

Genlabs Strike Bac Antibacterial Handsoap 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

Genlabs Strike Bac Antibacterial Handsoap

Drug Facts

Active Ingredient

Chloroxylenol 0.25%




  • For handwashing to decrease bacteria on the skinrecommended for repeated use


For external use onlyDo not use in the eyes. In case of contact, flush thoroughly with water.

Stop use and ask a doctor if irritation and redness develop, or if 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.


Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 15 seconds. Rinse and repeat.

Inactive Ingredients

5-Chloro-2-Methyl-4-Isothiazolin-3-One, Cocamide MIPA, Cocamidopropyl Betaine, DandC Red # 33, Fragrance, Glycerin, Glycol Distearate, 2-Methyl-4-Isothiazolin-3-One, Sodium Chloride, Sodium Laureth Sulfate, Water.

Strike Bac Antibacterial Handsoap

Strike Bac Antibacterial Handsoap is the ideal liquid hand soap because its antibacterial formula kills germs on contact and will effectively remove bacteria from the hands. Before using, consult supplier for further information and precautions, including Material Safety Data Sheets.Manufactured By: Genlabs 5568 Schaefer Ave., Chino, CA 91710 (909) 591-8451

* Please review the disclaimer below.