H3coh Hand Sanitizer
FDA Label NDC 77031-714

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Frozen Wheels, Llc for the product H3coh Hand Sanitizer (NDC 77031-714). 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, use[s], directions, other information, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Use[S]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Packaging

Image Description (Label3.1)

Image Description (Label3.1)

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