NDC 68978-141 Medi-hands

Chloroxylenol

NDC Product Code 68978-141

NDC 68978-141-04

Package Description: 3780 mL in 1 JUG

NDC Product Information

Medi-hands with NDC 68978-141 is a a human over the counter drug product labeled by Topmost Chemical & Paper Corporation. The generic name of Medi-hands is chloroxylenol. The product's dosage form is soap and is administered via topical form.

Labeler Name: Topmost Chemical & Paper Corporation

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.

Medi-hands 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 3.75 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)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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: Topmost Chemical & Paper Corporation
Labeler Code: 68978
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: 05-06-2014 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.

Medi-hands 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

Medi-Hands

​Active IngredientChloroxylenol 0.375%

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

  • 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.

  • Directions​Read the entire label before using this product.​Dispense 1-2 pumps of product onto wet palm.Lather and rinse hands with clean water

Inactive Ingredients​Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

PurposeAntibacterial

Medi-HandsKEEP OUT OF REACH OF CHILDREN

Medi-Hands Pearlized Antibacterial Skin Cleanser With Pcmx Distributed By: Topmost Chemical & Paper Corp. 3394 Winchester Rd. Memphis, Tn 38118 (901) 363-7278

14104-00_Topmost_MediHands

* Please review the disclaimer below.