Hand Sanitizer
FDA Label NDC 80574-101

9 label sections · Submitted to the FDA by Alexander Sprekenhus As · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alexander Sprekenhus As for the product Hand Sanitizer (NDC 80574-101). 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, uses, warning, 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

ISOPROPYL ALCOHOL  70%

Purpose

ANTISEPTIC

Uses

Apply to hands, and rub to help reduce bacteria that potentially can cause disease.

Warning

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.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Directions

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

Other Information

  • Store between 15-30° C {58-86° F)
  • Avoid freezing and excessive heat above 40° C (104° F)

Inactive Ingredients

WATER (AQUA), CARBOMER, GLYCERIN, TRIETHANOLAMINE, FRAGRANCE (PARFUM)

Package Label.Principal Display Panel

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