Biopure Antibacterial Hand Wipe Cloth
FDA Label NDC 78691-017

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quest Usa Corp for the product Biopure Antibacterial Hand Wipe (NDC 78691-017). 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 ingredient, purpose, uses, warnings, do not ues, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

  • Hand sanitizer to help reduce bacteria.
  • For use when soap and water are not available.

Warnings

For external use only.

Do Not Ues

  • in children less than 2 months old.
  • on open skin wounds.

When Using This Product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply to hands, allow to air dry without wiping.
  • Children under 6 years of age should be supervised when using this product.

Other Information

  • Store in a cool, dry place.
  • Avoid freezing and excessive heat.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Alpha-Tocopherol, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

Questions?

call 718-975-2586

78691-017-00

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78691-017-01

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