Shield-ex Hand Sanitizer
FDA Label NDC 80736-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amemed for the product Shield-ex Hand Sanitizer (NDC 80736-002). 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, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label - principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethanol Alchohol 70%

Use

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

For External Use Only - hands.

Ask a doctor if (a) irritation & redness develop or (b) condition persists for more than 72 hours.

Caution: Keep out of reach of children. Avoid contact with mucus membrane, harmful if swallowed.

Stop use and ask a doctor if skin irritation develops.

Otc - Keep Out Of Reach Of Children

Directions

  • Wet hands thoroughly with product and rub hands together until dry.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

    • Other information

    Flammable, do not store above 40 °C.
    May discolor some fabrics. May be harmful to wood finishes and plastic.

Inactive Ingredients

Purified Water, Carbomer, lsopropanol, lsopropyl Myiristate, Diisopropyl Sebacate, Propylene glycol, Aminomethyl Propanol, Fragrance Yellow 5, Blue 1.

Package Label - Principal Display Panel

Label (Label)

Label (Label)

* Please review the disclaimer below.