Ke-53ps Hand Sanitizer
FDA Label NDC 64121-515

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kinzua Environmental Inc. for the product Ke-53ps Hand Sanitizer (NDC 64121-515). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, principal display panel – bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Other Information

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

Otc - Active Ingredient

Active Ingredient:

Ethanol (60% v/v)

Otc - Purpose

Purpose:

Anti-Microbial Hand Sanitizer

Indications & Usage

Uses

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

Warnings

Warnings

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

Dosage & Administration

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.

Inactive Ingredient

Inactive Ingredients

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

Principal Display Panel – Bottle Label

KE-53PS
Gel Hand Sanitizer

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

    • For Hospital and Professional Use Only
    See Drug Facts panel for additional information

    12-266-1362
    Manufactured for:
    KINZUA ENVIRONMENTAL, Inc.
    1176 E. 38th. • CLEVELAND, OH 44114
    1-800-233-5079

    Principal Display Panel – Bottle Label (Kin02 0000 01)

    Principal Display Panel – Bottle Label (Kin02 0000 01)

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