• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Formulary
    • Exclusives
    • Top Companies
    • Raw Materials
    • End-User
    • Packaging
    • Directories
    • Events
    • Jobs
    • More
  • Magazine
  • News
  • Formulary
  • Exclusives
  • Top Companies
  • Raw Materials
  • End-User
  • Packaging
  • Directories
  • Events
  • Jobs
  • Current / Back Issues
    Features
    Columns
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Stepping into the Spotlight for 2021

    The Independent Beauty Association Supports Sensible Reform

    Essential Workers

    A Clean Commitment

    Deliver & Delight
    Online Exclusives
    Association News
    Breaking News
    Financial News
    Industry News
    International
    Marketing News
    New Products
    News Front
    Packaging News
    Patents
    Personnel
    Regulations
    Snapshots
    Top News
    Live From Shows
    Top News
    Associations Congratulate Biden & Harris

    David Stanko Joins JPMS

    Ross Introduces Double Cone Tumble Blender

    Colonial Chemical Announces New Facility

    Ashland Acquires Schülke & Mayr's Personal Care Business
    Blog
    Online Exclusives
    Infographics
    Podcasts
    Whitepapers
    Videos
    Expert's Opinion
    HappiTV
    eBook
    Surveys
    International Top 30 Report
    Top 50 Report
    Top Companies
    9. Amorepacific

    42. Herbalife

    23. Rodan + Fields

    6. Reckitt Benckiser

    19. New Avon
    Actives
    Functional Ingredients
    Pigments
    Polymers
    Preservatives
    Surfactants

    Associations Congratulate Biden & Harris

    Ashland Acquires Schülke & Mayr's Personal Care Business

    FDA Issues New Guidance On Pharmaceutical Alcohol

    No7 Adds At-Home Resurfacing Peel

    A Surge in Interest for Supplements & Vitamins
    Air Care/Environmental Fragrance
    AP/Deo
    Color Cosmetics
    Disinfectants
    Fine Fragrance
    Hair Care
    Household Cleaning
    I&I Marketplace
    Laundry Care
    Oral Care
    OTC/Medicated
    Packaging
    Personal Cleansers
    Skin Care
    Sun Care
    Testing

    David Stanko Joins JPMS

    Ashland Acquires Schülke & Mayr's Personal Care Business

    FDA Issues New Guidance On Pharmaceutical Alcohol

    State Announces First SARS-CoV-2 Kill Claim

    No7 Adds At-Home Resurfacing Peel
    Lab Equipment
    Mixing
    Packaging
    Testing

    Ross Introduces Double Cone Tumble Blender

    Happi Talks: Overnight Labels

    Three Form Vertical Beauty Alliance

    Logo Design Trends for 2021 & Beyond

    Coming Clean About Stink
    Contract Manufacturing / Private Label Directory
    Buyer's Guide
    Add New Company
    Corporate Profiles
    International Buyers Guide Companies
    Croda

    LipoTrue Inc.

    Siltech Corporation

    Centerchem Inc

    Vantage Specialty Ingredients
    Live From Shows
    Meetings
    Webinars
    Snapshots
    • Magazine
      • Current / Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Formulary
    • Directories
      • Buyer's Guide
      • Contract Manufacturing / Private Label Directory
      • Corporate Profiles
      • Add Your Company
    • Raw Materials
      • Actives
      • Functional Ingredients
      • Pigments
      • Polymers
      • Preservatives
      • Surfactants
    • End-User
      • Air Care/Environmental Fragrance
      • AP/Deo
      • Color Cosmetics
      • Disinfectants
      • Fine Fragrance
      • Hair Care
      • Household Cleaning
      • I&I Marketplace
      • Laundry Care
      • Oral Care
      • OTC/Medicated
      • Packaging
      • Personal Cleansers
      • Skin Care
      • Sun Care
      • Testing
    • Packaging
      • Lab Equipment
      • Mixing
      • Packaging
      • Testing
    • Top Companies
      • International Top 30 Report
      • Top 50 Report
    • Online Exclusives
    • Experts Opinion
    • Slideshows
    • HappiTV
    • Videos
    • Podcasts
    • eBook
    • Infographics
    • Blog
    • Whitepapers
    • Surveys
      • R & D Salary Survey
      • Sales & Marketing Salary Survey
    • Job Banks
    • Events
      • Industry Events
      • Live from show Events
      • Webinars
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Issues Final Rule on Hand Sanitizers

    ...

    Related CONTENT
    • Sunscreen Symposium Starts Thursday!
    • New FDA Warning Letters
    • FDA on CBD
    • FDA Puts Hold on Repeal of Lead Acetate in Hair Dyes
    • FDA Sends Warning Letter to Laboratoires Clarins
    07.01.19
     Three active ingredients—benzalkonium chloride, ethyl alcohol and isopropyl alcohol—are being deferred from further rulemaking to allow for ongoing study, said the US Food and Drug Administration when it issued a final rule on hand sanitizers available over-the-counter (OTC).

    The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water and marketed under the FDA’s OTC Drug Review.

    The final rule also seeks to ensure that the agency’s safety and effectiveness evaluations and determinations for consumer antiseptic rub active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and increasing use patterns.

    At press time, FDA said three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products.

    Their status will be addressed either after completion and analysis of the studies or at another time, if these studies are not completed.

    At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market. Less than 3% of the marketplace will be affected by the issuance of this final rule, as most OTC consumer antiseptic rubs use ethyl alcohol as the active ingredient.

    This final rule completes a series of rulemaking actions in the FDA’s ongoing review of OTC antiseptic active ingredients.
    Related Searches
    • ingredients
    • drug
    • it
    • safety
    Related Knowledge Center
    • Skin Care
    • Actives
    Suggested For You
    Sunscreen Symposium Starts Thursday! Sunscreen Symposium Starts Thursday!
    New FDA Warning Letters New FDA Warning Letters
    FDA on CBD FDA on CBD
    FDA Puts Hold on Repeal of Lead Acetate in Hair Dyes FDA Puts Hold on Repeal of Lead Acetate in Hair Dyes
    FDA Sends Warning Letter to Laboratoires Clarins FDA Sends Warning Letter to Laboratoires Clarins
    FDA Issues Final Guidance on MUsT for OTC Monograph FDA Issues Final Guidance on MUsT for OTC Monograph
    Active Ingredients from Ceapro Active Ingredients from Ceapro
    FDA Hosting Public Meeting To Prep for ICCR-13 FDA Hosting Public Meeting To Prep for ICCR-13
    FDA Issues Final Rule on Consumer Hand Sanitizers FDA Issues Final Rule on Consumer Hand Sanitizers
    FDA Proposal: Part I Is the Wait Finally Over? FDA Proposal: Part I Is the Wait Finally Over?
    FDA Puts Hold on Repeal of Lead Acetate in Hair Dyes FDA Puts Hold on Repeal of Lead Acetate in Hair Dyes
    Asbestos? In Cosmetics? Asbestos? In Cosmetics?
    Read FDA Read FDA's Statement on Cosmetics Safety
    FDA Commissioner To Resign, Reports Say FDA Commissioner To Resign, Reports Say
    FDA Advances Proposed Rule on Sunscreens FDA Advances Proposed Rule on Sunscreens

    Related Breaking News

    • Actives | Functional Ingredients
      Associations Congratulate Biden & Harris

      Associations Congratulate Biden & Harris

      Personal Care Product Council and American Cleaning Institute executives look forward to working with the new Administration.
      Happi Staff 01.20.21

    • Actives | Functional Ingredients | Household Cleaning | Personal Cleansers | Preservatives | Skin Care
      Ashland Acquires Schülke & Mayr

      Ashland Acquires Schülke & Mayr's Personal Care Business

      All-cash transaction expected to close later this year.
      Happi Staff 01.20.21

    • Actives | Functional Ingredients | Oral Care | Personal Cleansers
      FDA Issues New Guidance On Pharmaceutical Alcohol

      FDA Issues New Guidance On Pharmaceutical Alcohol

      Agency has concerns about methanol contamination in drug products other than hand sanitizer.
      Happi Staff 01.20.21


    • Skin Care

      Putting a Number on the Clean Beauty Market

      Global market to post 12.7% CAGR through 2027.
      Happi Staff 01.20.21

    • Actives | Skin Care
      No7 Adds At-Home Resurfacing Peel

      No7 Adds At-Home Resurfacing Peel

      Contains 15% glycolic acid.
      Happi Staff 01.20.21

    • Skin Care
      Alastin Named a Fast-Growing Brand

      Alastin Named a Fast-Growing Brand

      Professional skin care brand marks fourth year in a row in Kline's report.
      Happi Staff 01.20.21


    • Hair Care | Oral Care | Personal Cleansers | Skin Care
      P&G & the Post-Pandemic Shopper

      P&G & the Post-Pandemic Shopper

      The move toward e-commerce is permanent, according to executives.
      Happi Staff 01.20.21

    • Actives | Functional Ingredients | Hair Care | Skin Care
      A Surge in Interest for Supplements & Vitamins

      A Surge in Interest for Supplements & Vitamins

      Hyaluronic acid supplements searches soar more than 38%, according to Spate.
      Happi Staff 01.19.21

    • Skin Care
      Gattefossé Launches Inspiration Collection

      Gattefossé Launches Inspiration Collection

      Highlights current trends and different kinds of creativity with six new formulas.
      Happi Staff 01.19.21


    • Actives | Color Cosmetics | Hair Care | Pigments | Skin Care | Surfactants
      Nailing It in 2020

      Nailing It in 2020

      Consumer demand for hair color and nail care soared during the past year, according to IRI.
      Happi Staff 01.17.21

    • Hair Care | Oral Care | Skin Care | Surfactants
      P&G, L

      P&G, L'Oréal & Amorepacific Make News at CES

      Here's a look at what you're reading for the week ended January 16.
      Happi Staff 01.17.21

    • Actives | Functional Ingredients | Household Cleaning | Surfactants
      PurposeBuilt Brands Files for IPO

      PurposeBuilt Brands Files for IPO

      Seeks to raise as much as $100 million in an initial public offering.
      Happi Staff 01.16.21


    • Color Cosmetics | Fine Fragrance | Packaging | Packaging | Personal Cleansers | Skin Care
      Three Form Vertical Beauty Alliance

      Three Form Vertical Beauty Alliance

      Mana, Meiyume and RPG team up to offer end-to-end beauty solutions.
      Happi Staff 01.15.21

    • Functional Ingredients | Personal Cleansers | Skin Care
      Amyris Named a Top Social & Environmental Impact Company

      Amyris Named a Top Social & Environmental Impact Company

      Recognized by Real Leaders as a 'force for good.'
      Happi Staff 01.15.21

    • Skin Care | Sun Care
      Ashland Launches Antaron ECo Gel

      Ashland Launches Antaron ECo Gel

      New ingredient offers a lighter feel ideal for gel, lotion, milk, or spray formulas.
      Happi Staff 01.14.21

    Trending
    • Nu Skin Launches ‘Clean’ Formula Line
    • L'Oréal Bans Animal Hair In Brushes
    • Honest, Refillable Cleaners
    • Formulating Liquid Laundry Detergents
    • P&G & The Post-Pandemic Shopper
    Breaking News
    • Associations Congratulate Biden & Harris
    • David Stanko Joins JPMS
    • Ross Introduces Double Cone Tumble Blender
    • Colonial Chemical Announces New Facility
    • Ashland Acquires Schülke & Mayr's Personal Care Business
    View Breaking News >
    CURRENT ISSUE

    January 2021

    • Stepping into the Spotlight for 2021
    • The Independent Beauty Association Supports Sensible Reform
    • Essential Workers
    • A Clean Commitment
    • Deliver & Delight
    • Reusables for Consumables In the Pandemic and Beyond
    • A Rebound for Beauty
    • Beauty Brands Must Prepare for a 'Decade of the Home'
    • A Societal Shift
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Ingredient Manufacturers Discuss the E-Sports Market
    Euromonitor Names Top Ten Trends for 2021
    Study Highlights Differences Between EPA's and DHA's Effect on Sleep
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Launches Graphene Reinforced Dual System Ceramic Coating
    Miller Paint Declares Simple Serenity its 2021 Color of the Year
    TAUBMANS Paint by PPG Releases ‘Chromatic Joy’ Palettes
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Eitan Medical Receives FDA Clearance for Sapphire Infusion System
    Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial
    RSIP Vision Announces Versatile Medical Image Segmentation Tool
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Global Biosciences Co. Selects ValGenesis VLMS
    Eisai Appoints Chief Clinical Officer of Oncology Biz
    Nexelis Acquires GSK Vax Lab in Marburg
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Top Beauty Brands in the World—And Most Loved Fragrances
    P&G Reports Q2 Results
    A Lacquering Technique Makes Very Good Girl by Carolina Herrera Shine
    Happi

    Latest Breaking News From Happi

    Flow Launches Collagen Waters
    Associations Congratulate Biden & Harris
    David Stanko Joins JPMS
    Ink World

    Latest Breaking News From Ink World

    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    THIMM Group Installs 1st Koenig & Bauer CorruFLEX
    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Domino grows installation and service teams
    ABG keeps pace with demand with recruitment drive
    Acucote expands FSC-certified portfolio
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    First Quality Launches Incognito by Prevail
    Essity Launches Reusable Underwear Product
    Honeywell Delivered 225 Million Masks in December
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    DJO Acquires Trilliant Surgical
    FDA Breakthrough Device Designation Granted to Spiderwort's Spinal Cord Technology
    Bioventus Appoints SVP of Operations
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login