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Product NDC Code | 68605-1040 | ||||||||
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Drug Name | A-cute derm b-kleer |
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Type | Brand | ||||||||
Active Ingredients |
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Route | CUTANEOUS | ||||||||
Dosage Form | GEL | ||||||||
RxCUI drug identifier | 1243889 | ||||||||
Application Number | M004 | ||||||||
Labeler Name | ABBE Laboratories, Inc. | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Benzethonium Chloride (0.2%)
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 •Wet hands and other areas to be treated. •Place a small amount of gel in your hands and work into lather. •Apply lather to areas to be treated using a gentle, circular motion. •Rinse clean.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Hydroxypropyl Bis-Hydroxyethyl-dimonium Chloride, Propylene Glycol, Hydroxypropylmethylcellulose, Sodium Chloride, Diazolidinyl Urea, PEG-4 Laurate, Methylparaben, Propylparaben, 3-iodo-2-propynylbutylcarbamate.
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 B-KLEER™ is a unique, non-drying cleanser. •Designed for all skin types and pH balanced. •Excellent for postoperative care. •May be used as a topical antimicrobial to help protect against skin infection.
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.A-Cute Derm B-Kleer Benzethonium Chloride LAURAMIDOPROPYL BETAINE PROPYLPARABEN PROPYLENE GLYCOL BENZETHONIUM CHLORIDE BENZETHONIUM WATER AMMONIUM LAURYL SULFATE HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE HYPROMELLOSES SODIUM CHLORIDE DIAZOLIDINYL UREA PEG-4 LAURATE METHYLPARABEN IODOPROPYNYL BUTYLCARBAMATE
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.Principal Display Panel A-Cute Derm medical skincare B-Kleer TM Antimicrobial Cleansing Gel 4.0 FL OZ (118.29 ml) antimicrobial
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information •Alcohol Free •Moisturizes •Made in USA
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments Distributed. by ABBE Laboratories, Inc. 1095 Route 110 Farmingdale, NY 11735 1-800-457-0990
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 in eyes. Ask a doctor before use if you have deep wounds or puncture wounds. Stop use and ask a doctor if irritation develops. Keep out of reach of children.
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