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Product NDC Code | 78280-401 | ||||
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Drug Name | Kericleanz antiseptic |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
Application Number | M003 | ||||
Labeler Name | Kericure Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Hydrogen Peroxide 1% (v/v)
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 Use: Gently invert bottle to evenly mix. Apply spray to skin or wound to fully cover area. Bubbling may occur as it cleanses wound. Reapply as needed or as directed by a physician. Can be applied to gauze or dressings to pack into wounds. Stop use if condition worsens.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Purified water, silver hydrosol (proprietary)
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: Antimicrobial skin cleanser helps reduce bacteria that potentially cause infection • For general skin and wound cleaning.
Purpose
Information about the drug product’s indications for use.Purpose Topical Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.KeriCleanz ANTISEPTIC Hydrogen Peroxide HYDROGEN PEROXIDE HYDROGEN PEROXIDE WATER SILVER
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.Packaging KeriCleanz
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
• Skin and Wound Cleanser • Disrupts Biofilms • Potent Antimicrobial • No Rinse Formula Made in the USA KeriCure Medical Baltimore, MD 21229
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 ; for children 2 and under consult a physician before use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? [email protected]
Storage and handling
Information about safe storage and handling of the drug product.Other Information: Store between 20-25°C (68-77°F). Avoid direct sunlight.
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. Do not ingest. Do not use if allergic to ingredients. Discontinue use if irritation, redness or pain develops. If condition persists, consult a doctor. Keep out of reach of children ; for children 2 and under consult a physician before use.
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