Otc - Active Ingredient
Benzethonium Chloride - 0.2%
Zylastxp Antiseptic
FDA Label NDC 57362-464
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Innovative Biodefense for the product Zylastxp Antiseptic (NDC 57362-464). 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 otc - active ingredient, otc - purpose, otc - ask doctor, otc - keep out of reach of children, dosage & administration, warnings, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Otc - Ask Doctor
Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
If swallowed, immediately call Poison Control Center of doctor.
Dosage & Administration
Wet hands thoroughly with product and allow to dry without wiping.
Warnings
For external use only. Avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water. Discontinue use if irriation and redness develops. Consult a doctor if condition persists for more than 72 hours.
Inactive Ingredient
Water, Alcohol Denat., Cetearly Alcohol, Glycerin, Polyaminopropyl Biguanide, Dimethicone, Stearamidopropyl Dimethylamine, Benzyl Alcohol, Farnesol, Pantenol, Zinc Gluconate, Chlohexidine Digluconate, Citric Acid, Polyquaternium-10, Tocopheryl Acetate.
Indications & Usage
Handwash to decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use.
Package Label.Principal Display Panel
NDC 57362-464-00
ZylastXP Antiseptic Lotion 2oz
Broad Spectrum
Antimicrobial
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