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Product NDC Code | 49436-291 | ||||
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Drug Name | Purklenz |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 247396, 1537468 |
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Application Number | M003 | ||||
Labeler Name | PurKlenz Formulations Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Drug Facts Active Ingredient: Chloroxylenol 3.0%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions For best results do not dilute Apply as needed Scrub thoroughly for 30 seconds Wipe excess with sterile gauze Repeat - liquid only Massage package and remove towelette - towelette only Fold gauze and repeat - towelette only
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (aqua), Sodium Laureth Sulfate, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Hypromellose, Citric Acid, Tetrasodium EDTA, Lanolin Oil
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses To decrease bacteria on the skin
Purpose
Information about the drug product’s indications for use.Purpose Purpose: Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.PurKlenz CHLOROXYLENOL CHLOROXYLENOL CHLOROXYLENOL WATER SODIUM LAURETH SULFATE PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE PPG-2 HYDROXYETHYL COCAMIDE HYPROMELLOSES CITRIC ACID MONOHYDRATE EDETATE SODIUM LANOLIN OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PurKlenz Antiseptic Skin Cleaner Label - 30 FL Oz PurKlenz® Antiseptic Skin Cleanser Chloroxylenol 3.0 % NO PARABEN • ALCOHOL • DYE • FRAGRANCE• Contains No Paraben, Fragrance or Dye 30 FL. OZ. (900 mL) NDC 49436-291-01 Made in Canada Distributed in U.S.A. by PurKlenz Formulations Inc. Questions or Comments? www.purklenz.com PURKlenz PurKlenz Formulations Inc. PurKlenz AntisepticSkin 5 Label
PurKlenz Antiseptic Skin Cleanser - Towelette Label PurKlenz® Antiseptic Skin Cleanser Contains No Paraben, Fragrance and Dye 1 Pre-moistened Single Use Towelette 4" X 6" Net Content 3.5 mL NDC 494-291-03 PurKlenz AntiTowellette Label PurKlenz AntiTowelette 1 Label
PurKlenz Antiseptic Skin Cleaner - Drum Label PurKlenz® Antiseptic Skin Cleanser Gross weight 111 kg (278 lbs) Net weight 105 kg (263 lbs) Volume 105 Liters (28 Gallons) NDC 494-291-99Lot 4D1 MADE IN CANADA Expiry April 2016 PurKlenze Formulations Inc. PurKlenz Drum Label
PurKlenz Antiseptic Skin Cleaner Label - 16 FL Oz PurKlenz ® Antiseptic Skin Cleanser NO - Paraben – Alcohol – Dye - Fragrance 500mL (16 FL. OZ.) NDC: 49436-291-05 Product Facts Active ingredien Purpose: Chloroxylenol 3%.............................Antiseptic Uses: To decrease bacteria on the skin. Warnings: For external use only. Do not ingest. Do not use if you are allergic or sensitive to any of the ingredients listed. When using this produc t avoid contact in or near eyes and mouth (oral mucosa). In case of eye contact, flush eyes with water. Stop use & ask a doctor if irritation, rash or other allergic reaction develops. Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center right away. Directions: For best results do not dilute Apply as needed Scrub thoroughly for at least 30 seconds Rinse Repeat Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F) Inactive ingredients: Water (aqua), Sodium Laureth Sulfate, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Hypromellose, Citric Acid, Tetrasodium EDTA, Lanolin Oil Made in Canada Distributed in U.S.A. by PurKlenz Formulations Inc. Questions or Comments? www.purklenz.com res PurKlenz 500mL 05
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children Keep out of reach of children. In case of accidental ingestion seek medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Other Information: Reseal container after use - liquid only Avoid freezing Store between 4° - 30° C (40-86° F) Dispose after use - towelette only
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Do not use if you are allergic or sensitive to any of the ingredients listed When using this product avoid contact in or near eyes and mouth (oral mucosa). In case of eye contact, flush eyes with water. Stop and ask a doctor if irritation, rash or other allergic reaction develops. In case of accidental ingestion seek medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API