Envirokleen Instant Hand Sanitizer
FDA Label NDC 50112-515

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Envirokleen Llc for the product Envirokleen Instant Hand Sanitizer (NDC 50112-515). 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 other, active ingredient:, purpose:, uses, warning, otc - keep out of reach of children, directions, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient:

Ethanol (60% v/v)

Purpose:

Anti-Microbial Hand Sanitizer

Uses

  • Helps reduce bacteria that potentially can cause disease
  • Helps prevent cross contamination by hand contact
  • Recommended for repeated use

Warning

  • For external use only
  • Flammable, keep away from fire, heat, or flame

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.
  • Do not use near eyes
  • In case of eye contact flush with water for 15 minutes
  • If irritation persists stop use of product and get medical attention
  • In case of accidental ingestion seek medical attention or contact a poison control center immediately.

Directions

  • Use no water or towels
  • Apply appropriate amount of product to palm of hand
  • Rub until hands are completely covered
  • Agitate lightly until dry
  • Let air dry for 15 seconds
  • Do not rinse or wipe with towel.

Other Information:

  • Store in a cool dry place below 104° F.

Inactive Ingredients:

Water, Carbomer, Triethanolamine, PEG-75 Lanolin, Aloe Vera Gel, Fragrance.

Principal Display Panel

ECS Envirokleen Instant Hand Sanitizer

  • Enhanced with Moisturizers
  • Kills disease causing germs within seconds
  • Effective against MRSA, VRE, E. coli (0157:H7)
    Staphylococcus, Streptococcus & other organisms
  • Assists with OSHA Bloodborne Pathogen Standard Compliance

    • See Drug Facts panel for additional information.
    For Hospital And Professional Use Only
    Envirokleen, LLC
    3313 South Arlington Avenue
    Indianapolis, Indiana 46203
    Phone 317-352-1941 Fax 317-352-1946
    Website: www.ecsenvirokleen.com

    “Environmental Cleaning Solutions”

    Align the half moon ears (round side out) with
    the slots of the dispenser's lower docking area.
    Press top and bottom of tube firmly into place.

    KEEP OUT OF REACH OF CHILDREN.

    Principal Display Panel (Env02 0000 01)

    Principal Display Panel (Env02 0000 01)

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