Shieldplex Hand Sanitizer
FDA Label NDC 75490-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clt Logistics Inc. for the product Shieldplex Hand Sanitizer (NDC 75490-003). 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[s], warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Use[S]

To help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together for 15 seconds until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store between 15-300C (59-860F)
  • Avoid freezing and excessive heat above 400C (1040F)

Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Denatonium Benzoate.

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