1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

OTC Benzocaine Needs Label Warning, Indication Change – Public Citizen

 
• By Malcolm Spicer

In a citizen petition the group asks FDA to remove teething for children 2 years and older as an indication for some benzocaine products and require a label warning for OTC monograph benzocaine products concerning the risk of methemoglobinemia.

Allowing firms the option of including a label warning about potential methemoglobinemia risk from OTC benzocaine oral care products is not enough, Public Citizen argues in a citizen petition to substantially change the product labels.

The advocacy group asks FDA to remove teething for children 2 years and older as an indication for benzocaine OTC oral health care products and require a contraindication on labels advising against using

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

More from North America

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.