NDC 50685-008 Good Care Sterile Scrub Brush With Pcmx

Chloroxylenol

NDC Product Code 50685-008

NDC CODE: 50685-008

Proprietary Name: Good Care Sterile Scrub Brush With Pcmx What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Chloroxylenol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 50685 - Dalian Goodwood Medical Care Ltd.
    • 50685-008 - Good Care Sterile Scrub Brush With Pcmx

NDC 50685-008-00

Package Description: 20 mL in 1 PACKET

NDC Product Information

Good Care Sterile Scrub Brush With Pcmx with NDC 50685-008 is a a human over the counter drug product labeled by Dalian Goodwood Medical Care Ltd.. The generic name of Good Care Sterile Scrub Brush With Pcmx is chloroxylenol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Dalian Goodwood Medical Care Ltd.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Good Care Sterile Scrub Brush With Pcmx 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 33 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5)) (UNII: 1KX12A42IJ)

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: Dalian Goodwood Medical Care Ltd.
Labeler Code: 50685
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: 02-13-2013 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: 12-31-2021 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.

Good Care Sterile Scrub Brush With Pcmx Product Label Images

Good Care Sterile Scrub Brush With Pcmx 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

3.3% Parachlorometaxylenol  Cleansing Solution With Emollient

Purpose

Antiseptic

Uses

  • For cleansing hands and arms prior to surgery

Warnings

  • For external use onlyDo not use in eyes

Otc - Stop Use

  • Stop use and ask a doctor if skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control right away

Directions

  • Wet hands and forearms with waterClean under nails with nail cleanerScrub for 3 minutes with the impregnated brushPay close attention to the nails, cuticles, and interdigital spacesRinse thoroughly with running waterRepeat

Other Information

  • Store at room temperatureAvoid excessive heat above 40 degrees C (104 degrees F)Protect from freezingLatex free

Inactive Ingredients

Citric Acid, PEG -120 Methyl Glucose Dioleate, Purified Water, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Sodium Lauryl Sulfate, Sodium Sulfonate, Soya Fatty Acid, Vinylpyrrolidone

Manufactured By Dalian Goodwood Medical Care Ltd.

Made in China

* Please review the disclaimer below.