NDC 65601-708 Antibacterial Skin Cleanser

Chloroxylenol

NDC Product Code 65601-708

NDC 65601-708-04

Package Description: 3780 mL in 1 JUG

NDC 65601-708-10

Package Description: 1100 mL in 1 BAG

NDC 65601-708-19

Package Description: 900 mL in 1 BAG

NDC 65601-708-29

Package Description: 1000 mL in 1 BAG

NDC 65601-708-55

Package Description: 207900 mL in 1 DRUM

NDC 65601-708-88

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC Product Information

Antibacterial Skin Cleanser with NDC 65601-708 is a a human over the counter drug product labeled by Betco Corporation, Ltd.. The generic name of Antibacterial Skin Cleanser is chloroxylenol. The product's dosage form is soap and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1362618.

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.

Antibacterial Skin Cleanser 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.


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)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALCOHOL (UNII: 3K9958V90M)
  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
  • 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: Betco Corporation, Ltd.
Labeler Code: 65601
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: 11-12-2012 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 - 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.

Antibacterial Skin Cleanser Product Label Images

Antibacterial Skin Cleanser 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

Otc - Active Ingredient

​Active IngredientChloroxylenol 0.375%

Indications & Usage

  • Uses​​Antibacterial hand cleaner.Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

Warnings

  • WarningsFor external use only.Avoid contact with eyes.Children under the age of 6 should be supervised by an adult when using this product.Discontinue use is irritation or redness develops.If irritation persists for more than 72 hours, consult a physician.KEEP OUT OF REACH OF CHILDREN.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directions​Read the entire label before using this product.​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.Rinse with clean water.

Inactive Ingredient

Inactive Ingredients​Water, Sodium Laureth lSulfate, Cocamidopropyl betadine, Phenoxyethanol, Coco MIPA, Glycol Stearate, DMDM Hydantoin, Propylene Glycol, Sodium Chloride, Fragrance, Glycerin, Ethanol,  D&C Green #5, FD&C Yellow #5.

Otc - Purpose

PurposeAntibacterial

Otc - Keep Out Of Reach Of Children

Winning Hands AntibacterialKEEP OUT OF REACH OF CHILDREN

* Please review the disclaimer below.