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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Sani Home Products International Llc for the product Pristall Sanishield Alcohol Free Antiseptic Hand Sanitizer (NDC 50757-250). 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 other, otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active Ingredient Purpose
Benzalkonium Chloride 0.13 percent Antiseptic
Uses
For hand washing to decrease bacteria on the skin. Recommended for repeated use.
Warnings
For external use only.
Do not use in eyes.
Discontinue if irritation or redness develop. If condition persists for more than 72 hours, consult a doctor.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Wet hands thoroughly with product and allow to dry without wiping.
Inactive Ingredients
Cocoamidopropyl Betaine, Edetate Sodium USP Dihydrate, Fragrance, Hydroxypropyl Cellulose, Propylene Glycol, Water
Lot No. Expiration Date Made in USA Manufactured by: Sani Home Products International, LLC 15 Frowein Road Buiding E Suite 2 Center Moriches, NY 11934
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