First Dephense Alcohol-free Antiseptic Foam Hand Sanitizer
FDA Label NDC 76116-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Dephense, Llc for the product First Dephense Alcohol-free Antiseptic Foam Hand Sanitizer (NDC 76116-100). 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, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

  • For external use only.
    • Distributed by first depHense, LLC
    519 S. Main St., Sycamore, IL 60178

    Made in USA.

Otc - Active Ingredient

Active Ingredients

Benzalkonium Chloride 0.13%

Otc - Purpose

Purpose

Antimicrobial

Indications & Usage

Uses
  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

Warnings

Otc - Do Not Use

  • Do not use in eyes. If contact occurs, flush eyes with water.

Otc - Stop Use

  • Stop use and ask a doctor if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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.

Dosage & Administration

Directions
  • Pump a small amount of foam into palm of hand.
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Rub hands together briskly until dry.

Inactive Ingredient

Inactive Ingredients

Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

Package Label.Principal Display Panel

  • NO RINSE
  • MOISTURIZES
  • LEAVES SKIN SOFT

    • Up To 3 Times MORE APPLICATIONS
    THAN ALCOHOL-BASED GELS



    first depHense
    Protecting your health and environment

    ALCOHOL-FREE
    Antiseptic Foam Hand Sanitizer

    Eliminates 99.999%
    OF MOST COMMON GERMS THAT MAY CAUSE ILLNESS


    Environmentally  Friendly
    1.7 floz (50ml)

    Handsanitizer (Handsanitizer)

    Handsanitizer (Handsanitizer)


* Please review the disclaimer below.