Sopure
FDA Label NDC 80773-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Enviroserve Chemicals & Cleaners Ltd for the product Sopure (NDC 80773-002). 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, purpose, warnings, uses, directions, keep out of reach of children, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethanol USP 80%v/v

Purpose

Medicated Skin Cleanser Kills harmful bacteria/germs

Warnings

  • Avoid contact with eyes. In case of contact, rinse eyes thoroughly with water. 
  • If irritation develops, consult a doctor. Keep out of reach of children. 
  • Do not use on children / infants less than 2 years of age (unless directed by a doctor or physician). 
  • Ifswallowed, call a poison control center or get medical help right away. 
  • Keep away from open flame and sources of heat.

Uses

Hand Sanitizing wipes Kills harmful bacteria/germs.

Directions

Use as need on basis. Wipe your hands to help prevent spread of bacteria.

Keep Out Of Reach Of Children

Do not use on children / infants less than 2 years of age (unless directed by a doctor or physician.)

Inactive Ingredients

Water, glycerin, hydrogen peroxide, alpha tocopherol acetate

* Please review the disclaimer below.