PPB June 2020

your registration number and you submit your labeling and ingredients, [the FDA is] not going to inspect your facility—it is too busy for that. The FDA has relaxed some of its requirements because of the pandemic. It came out with a temporary policy for the preparation of certain alcohol-based hand sanitizer products to allow for a lot of new companies to enter this space. But that doesn’t give a brewery or a distillery free range to make anything; you still have to abide by formulations set forth by the World Health Organization and the FDA. It has to have a least 60 percent to 90 percent alcohol. Right now, we are producing [hand sanitizer] with 70-percent ethanol (alcohol), which complies with FDA and CDC guidance to kill germs. PPB What are the requirements for proper hand sanitizer labeling? Butler First of all, it has to be made in accordance with the ingredients that the CDC says are important. Sanitizers must be manufactured in preparation using ethanol that is not less than 94.4 percent by volume or a pharmacopoeia-grade isopropyl alcohol. There’s guidance on all the CDC websites. You have to use purified water, glycerin, hydrogen peroxide—so there is a list of ingredients that have to be adhered to. Then, once it’s batched up in a gel or liquid format, you then have to utilize drug fact labeling, which people have seen before on the bottles of name brand sanitizers you’d see at CVS or Walgreens. The label has to be in strict accordance with drug fact labeling or else it’s considered misbranded, mislabeled. It has to have an 800-number for poison control. All shipments have to be accompanied by a material safety data sheet. It tells you how to store the product, what to do if it’s ingested and to keep it away from the eyes. But beyond that, the front of the label has the flexibility to say “Compliments of [so-so business.]” That’s where private labeling comes in, but I see that more down the road. Right now, it’s more “get me what you can get me.” For health-care workers or others who are required to wear face masks for long periods, the Mask Buddy is an easy way to prevent sore ears. Two buttons on either side of the one-inch headband allow the wearer to loop the elastic of the face mask around the buttons for a perfect, painless fit. The imprint on the headband can be completely customized. SnugZ USA / PPAI 112982, S10 / www.snugzusa.com As your clients reopen, give their customers peace of mind as soon as they step through the door with this PureGel Spray Touchless Dispenser . This battery-operated, touchless hand sanitizer dispenser can be mounted on walls or placed on tables. Clients will appreciate this refillable dispenser as they grow their business and reconnect with partners. All DermaCare Line products are FDA-registered, CGMP- compliant and are made in North America. DermaCare Packaging & Private Labels, LLC / PPAI 537995, S1 www.dermacarepkg.com | JUNE 2020 | 41 GROW