Rough And Smooth Heavy Duty Antiseptic Hand Sanitizer
FDA Label NDC 90119-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Orbizorb Llc for the product Rough And Smooth Heavy Duty Antiseptic Hand Sanitizer (NDC 90119-001). 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 active ingredient, purpose, use, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

  • For hand washing to decrease bacteria on the skin

Warnings

For external use only

Do Not Use

in the eyes

Stop Use And Ask A Doctor If

  • irritation and 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

  • Peel back the foil seal and pull the center wipe through the slot in the lid.
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Close lid after use to prevent wipes from drying out.

Inactive Ingredients

Water, Estasol, Poloxalene, PEG-75 Lanolin, Glycerin, Aloe Barbadensis Extract, Polyethylene glycol, Lauryl Glycosides, Fragrance, Disodium EDTA, 2-bromo-2-nitropropane-1,3-diol, 1,2-benzisothiazolin-3-one.

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