D-col Personal Hygiene Convenience Kit

Pyrithione Zinc And Chloroxylenol

D-col Inc
Human Otc Drug
NDC 53205-001

D-col Personal Hygiene Convenience Kit also known as Pyrithione Zinc And Chloroxylenol is a human otc drug labeled by 'D-col Inc'. National Drug Code (NDC) number for D-col Personal Hygiene Convenience Kit is 53205-001. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in D-col Personal Hygiene Convenience Kit drug includes . The currest status of D-col Personal Hygiene Convenience Kit drug is Active.

Drug Information:

Drug NDC:	53205-001
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	D-col Personal Hygiene Convenience Kit
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Pyrithione Zinc And Chloroxylenol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	D-col Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Kit
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	30 May, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part358H
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.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	D-COL Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
53205-001-01	1 KIT in 1 CARTON (53205-001-01) * 15 mL in 1 PACKET * 1 mL in 1 PACKET * 7.4 mL in 1 PACKET	30 May, 2018	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

D-col Personal Hygiene Convenience Kit

Pyrithione Zinc And Chloroxylenol

Kit
D-COL Inc
NDC: 53205-001

Purpose:

Purpose antiseptic

Purpose anti-dandruff

Product Elements:

D-col personal hygiene convenience kit pyrithione zinc and chloroxylenol d-col pyrithione zinc pyrithione zinc pyrithione zinc water carbomer interpolymer type a (allyl sucrose crosslinked) sodium laureth-3 sulfate peg-90 diisostearate cocamidopropyl betaine coco diethanolamide cyclomethicone 5 edetate sodium caprylyl glycol sodium hydroxide d-col patient antiseptic skin preparation chloroxylenol chloroxylenol chloroxylenol propylene glycol coco diethanolamide ammonium lauryl sulfate sodium laureth-3 sulfate citric acid monohydrate edetic acid ammonium chloride propylparaben imidurea water d-col nasal inner rim cleanser benzalkonium chloride polysorbate 20 peach kernel oil glycereth-8 esters sodium chloride potassium sorbate sodium citrate, unspecified form xylitol edetate disodium lavender oil spearmint oil tea tree oil citric acid monohydrate

Indications and Usage:

Uses antiseptic skin cleansers help reduce bacteria that potentially causes disease. for patient antiseptic skin preparation (15 ml packets only). for healthcare personnel hand wash. for surgical hand scrub.

Uses for nasal inner rim cleanser.

Uses helps prevent recurrence of flaking and itching associated with dandruff.

Warnings:

Do not use if you or the patient is allergic to chloroxylenol or any other ingredient in this product. when using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums. if contact occurs in any of these areas, rinse with cold water right away. repeated general cleansing of large body areas should not be done except when advised by a health care provider. stop use and ask doctor if irritation, sensitization, or allergic reaction occurs. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for use only in the inner rim of each nostril. when using this product avoid contact with eyes. in case of eye contact, flush with water. stop use and ask doctor if irritation, discomfort, or redness develops. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warnings for external use only. when using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

When Using:

When using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums. if contact occurs in any of these areas, rinse with cold water right away. repeated general cleansing of large body areas should not be done except when advised by a health care provider.

When using this product avoid contact with eyes. in case of eye contact, flush with water.

When using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water.

Dosage and Administration:

Directions patient antiseptic skin preparation . thoroughly rinse the area to be cleansed with water. apply the minimum amount of the product necessary to cover the skin area and wash gently. rinse thoroughly with water. surgical hand scrub . wet hands and forearms with water. scrub for 3 minutes with about 5 ml of the product with a brush. rinse thoroughly under running water. healthcare personnel handwash . wet hands with water. dispense about 5 ml of the product into cupped hands and wash in a vigorous manner for 15 seconds. rinse and dry thoroughly.

Directions apply a reasonable amount of the product to the end of your index finger for a single nasal inner rim application. save a reasonable amount to apply to the opposite nasal inner rim. insert your index finger into one nostril no further than the inner rim, and cover the inner rim of the nasal passage with the product. do not apply the product beyond the inner rim of the nasal passage. repeat the application of the product to the untreated nasal inner rim. wait 30 seconds after you complete the application, and thoroughly wipe the inner rim of each nostril with a cloth wet with water. children under 6 years of age should be supervised when using this product.

Directions place enough product in your palm to thoroughly cover the scalp area. rub hands together until product covers entire surface of your palms. apply product to the scalp and thoroughly massage and cover the scalp. rinse with water until the product is completely removed from the application area. use one packet as directed. children under 6 years of age should be supervised when using this product.

Stop Use:

Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs.

Stop use and ask doctor if irritation, discomfort, or redness develops.

Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed.

Package Label Principal Display Panel:

Principal display panel - kit carton label dcol personal hygiene convenience kit patient antiseptic skin preparation chloroxylenol .24% (3 count, net wt. 15 ml per packet) shampoo zinc pyrithione 1.0% (3 count, net wt. 7.4 ml per packet) nasal inner rim cleanser organic (1 count, net wt. 1 ml) compare to active ingredient in hibiclens: fda: chlorhexidine gluconate can cause rare but serious life threatening allergic reaction. single use packets principal display panel - kit carton label

Further Questions:

Questions? (210)-227-3612

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.