NDC 73708-524 Carrollclean

Chloroxylenol (pcmx)

NDC Product Code 73708-524

NDC 73708-524-17

Package Description: 800 mL in 1 BAG

NDC 73708-524-28

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC 73708-524-84

Package Description: 473.176 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Carrollclean with NDC 73708-524 is a a human over the counter drug product labeled by Carrollclean Lcc. The generic name of Carrollclean is chloroxylenol (pcmx). The product's dosage form is soap and is administered via topical form.

Labeler Name: Carrollclean Lcc

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.

Carrollclean 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.

  • CHLOROXYLENOL .282 mg/100mL
  • CHLOROXYLENOL .282 mg/100mL
  • CHLOROXYLENOL .282 mg/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.

  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • C9-11 PARETH-8 (UNII: 80E6PSE1XL)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)

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.
  • 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.
  • 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: Carrollclean Lcc
Labeler Code: 73708
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: 09-16-2020 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.

Carrollclean Product Label Images

Carrollclean 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

Chloroxylenol 0.25% w/v

Purpose

Antimicrobial

Uses

  • Hand washing in public washrooms, work areas, healthcare facilities, office buildings, food service facilities, and whatever cleanliness and antimicrobial properties are desired.

Warnings

For external use only

When Using This Product

  • Do not use in or near eyes

Keep Out Of Reach Of Children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

  • Apply small amount of product to handshold hands under water and work cleaner into latherrinse with water and wipe clean

Other Information

  • Store at room temperature

Inactive Ingredients Section

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Dimethylol-5,5-dimethylhydantoin, Linear Ethoxylated Alcohol, Propylene Glycol, Polyethylene Glycol Distereate, Fragance, Tetrasodium EDTA, Methylchloroisothiazolinone (and) Methyllisothiazolinone, Isopropyl Myristate, Citric acid, FD & C Red #40, D & C Red #33

* Please review the disclaimer below.