Kericleanz Antiseptic Spray
FDA Label NDC 78280-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kericure Inc. for the product Kericleanz Antiseptic (NDC 78280-401). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses:, warnings:, otc - keep out of reach of children, directions for use:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Hydrogen Peroxide 1% (v/v)
Purpose
Topical Antiseptic
Uses:
Antimicrobial skin cleanser helps reduce bacteria that potentially cause infection • For general skin and wound cleaning.
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children; for children 2 and under consult a physician before use.
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.
Other Information:
Store between 20-25°C (68-77°F). Avoid direct sunlight.
Inactive Ingredients:
Purified water, silver hydrosol (proprietary)
Questions?
Packaging
Kericleanz (7828040110)
* Please review the disclaimer below.
