Hand sanitizer labeling warning issued by the FDA

Posted on Sep 20th 2007 7:35PM by Brian White

It's not the first time, but a new warning from the FDA to maker-of-everything Procter & Gamble says that the company should stop mis-labeling some of its hand sanitizer products that are marketed toward children (umm, to their parents, in all reality).

Procter and Gamble says that its Vicks Early Defense Foaming Hand Sanitizer prevents colds and provides up to three hours of antimicrobial activity. Problem is that those kinds of claims are not allowed under FDA regulations for such a product.

Those sound like medical claims to me, not cosmetic claims. Parents concerned about the constant hand sanitizing by children (for some reason) are, of course, attracted to the claims.

In general, clinical studies and loads of data are required by manufacturers to make claims like this on non-drug-products (and even on OTC drug products), so that kind of labeling will most likely be banished soon.

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Tags: germs, hand, portable, sanitizer

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Reader Comments (Page 1 of 1)

marcie0305 9-20-2007 @ 9:01PM

Jeez - hand sanitizers are actually much safer than anti-bacterial soap. I am guessing that the natural ingredient in Vicks is eucalyptis - and heaven forbid they make a claim about something that's been used for thousands of years. For more on antibacterial soap see:

http://feedingblackmail.blogspot.com/2007/08/what-you-didnt-know-about-antibacterial.html

alan 9-22-2007 @ 8:19PM

Must be made in China using battery acid from reclaimed batteries.

just saying 9-22-2007 @ 9:14PM

cleaning your hands at anytime with anything is much better for you than not cleaning them at all. the fda should get back to more important stuff, like getting unsafe and unproven prescription medicines off the market and out of people's lives! they know alternative medicines work just as good, but don't want to upset the "establishment".

used it 9-22-2007 @ 10:13PM

They have the same hand sanitizers at my job. My hands were getting rashes and I couldn't figure out from what.
A lady I work with said the same thing happaned to her and she stopped using it. As soon as I stopped using it the rashes went away.

Industrialmetalfreeeeek 9-22-2007 @ 10:23PM

The FDA should be investigating why their is a new food recall every other week and not worry about whether a hand sanitizer will prevent kids from getting a cold. The FDA is just like the majority of the other government agencies, absolutely useless.

Michele 9-22-2007 @ 10:27PM

The REAL truth about handwashing is that the flow of water, the emulsifiying action of ANY soap (breaks down skin oils and loosens the dirt) and the friction of rubbing your hands together are responsible for most of the "germ-fighting" activity. A vigorous plain old soap and water scrub for couple of minutes is all any of us really needs unless we're surgeons.

beau 9-22-2007 @ 10:45PM

Why does a picture of Purell (NOT the Vicks product & NOT even a P & G product) accompany this article??! Not fair to allude to this product as also being suspect!!!

stacy 9-22-2007 @ 10:58PM

This is not surprising to me at all. These products should never be used on children as they contain alcohol which there are reports of children getting very sick & even drunk on these products. The children that have been affected by sanitizers like Purell have used the amount as listed in the directions but ended up very sick. One two year old girl only licked her hand after using Purell & ended up with many problems that were later found to be alcohol poisioning. Another little boy ingested a small amount & he too was taken to the hospital with a blood alochol level 5x over the legal limit for an adult. I do not use any hand sanitizer with alochol in it on my three kids.

I have bought the No Rinse sanitizer & it works just fine without the alcohol problem hanging over my head. No Rinse like Purell, kills 99% of all germs in 30 seconds flat without the use of water. It's an antibacterial foaming cleanser. It is mom approved, , kid-friendly, non-drying & does NOT remove mom's nail polish like the other sanitizers. It also has a great scent that does not affect my asthma which makes it that much more of a great product in my book.

If you would like a 50mL sample (also comes in a gallon sized bottle & you can buy a dispenser for your office- great for doctors or in any bathroom) go to www.iambabycrazy.com/sschofill, fill out your contact info & I will send you your sample (a $5.95 retail value for free). The No Rinse is my top selling product & I guarntee that you will fall in love with this great product.

What are you waiting for? Save your child's life & avoid a costly mistake by making the switch to the safest hand sanitizer on the market.

Samantha Betenbough 9-22-2007 @ 11:05PM

It is OK to use hand sanitizer. Just do what I do and wash it off like it were soap, then use a hand lotion of some sort to add moisture back and help prevent dryness.

Hand sanitizers tend to have a high alcohol level, thus drying out your hands. You can't prevent illnesses from happening, but any small step will help you fight germs to a degree.

Remember.. KEEP YOUR HANDS AWAY FROM YOUR FACE IN PUBLIC.

luba27 9-23-2007 @ 10:52AM

That's right...it's all a conspiracy. The FDA is in cahoots with big pharma to take your money and they push these bad drugs...alternative drugs are much better, there's proof that they work...oh, right, there isn't.

Look ah...people (restraining myself from using other words)...the FDA is certainly not perfect, but for better or for worse it is there to protect you from quacks who say "this here (insert whatever) cures everything you got" without proof (which includes randomized, controlled clinical trials), and to make sure that benefits outweigh the risks - I know, I know there are deaths and other serious bad things that happen and companies are less than honest at times, and lobbyists influence the FDA and that's bad, but why don't people focus on that and try to fix it instead of discrediting the only agency that's there to enforce rigorous scientific standards is truly beyond me.

And while I'm not normally a defender of big pharma, I feel compelled to mention that without them, using the "alternative" treatments of the past, we would still have the life expectancy that we did in the past - which is far shorter than what we have now.

Oh - I don't work for "the man", or anything like that if any of you nut job conspiracy people are wondering. I'm just a normal, educated person.

Lisa 9-23-2007 @ 12:03AM

If you want to use a relatively safe hand sanitizer, buy everclear, and dilute it 2.5 parts water (tap water is best) to 7.5 parts everclear. Put it in a spray bottle, and spritz as needed. DO NOT spray or store near an open flame. Equally good--just use straight Bacardi 151 Rum. Other than the risk of a little buzz if you get overenthusiastic with using either of those, there really isn't any risk of poisoning if used moderately. Remember--if it's (relatively) safe to drink, it isn't dangerous to use on your skin in small amounts.

If there is no worry about overuse or someone drinking the stuff, put the GRAIN rubbing alcohol (aka ethanol--NOT isopropyl alcohol, 2-propanol, isopropanol, wood alcohol, methanol or methyl alcohol) in a spray bottle and use as needed. That's what's used in research laboratories all over the country. This is the least expensive option.

Mea 9-23-2007 @ 12:04AM

I don't believe that the amount of alcohol present in the dab you put on a child's hands could possibly cause alcohol poisoning. by the time I rub my kids' hands together it is already evaporated. It's great if you are somewhere you can wash hands, but that is not always possible. I try to use hand sanitizer when I am shopping; especially after I have used a shopping cart. Several weeks ago I forgot to do that after loading my car at the grocery store and I must have touched my eye or something. Anyway, I came down with a virus that put me in the bed for 3 days. You never know who has been touching shopping carts or baskets - yuck!

milliemartgirl 9-23-2007 @ 1:13AM

Why waste the money on hand sanitizer? Buy a bottle of rubbing alcohol for 50 cents and do the same thing...

Lauryn 9-23-2007 @ 1:52AM

The Triclosan that's used in most "antibacterial" soaps and hand sanitizers can help lead to antibiotic resistance, and especially has this ability when it pervades our waterways when you wash it off. Even if you don't care about the other chemicals that you're slathering on your hands along with the Triclosan, at least avoid this ingredient to help prevent antibiotic resistance, and just wait until you can wash your hands with regular soap and water, unless it's some huge emergency like doing immediate surgery without being able to wash your hands, or something like that.

wrestlersmom 9-23-2007 @ 3:27AM

I'm a nurse and have been using a combination of multiple brands of hand snaitizers AND handwashing. you can only imagine the stuff that gets onmy hands all day. I think that if people start having reactions to it they should just stop using it. I have had no reactions so i use it at work and at home. no matter how clean you think you home is, it's not. The whole principal of hand washing to prevent illness is a good one if its used. i think its ridiculous that a child can get alcohol poisoning from this stuff. pretty much impossible. the amount is so small that even if you used it 20 times a day you couldnt absorb enough alcohol to get a BAC of 5time times the legal limit. ultimately, washing hands is the best but only if its done right and children dont do it right, ok most adult dont either... or enough times. so i guess if you use the sanitizer it is better than nothing at all. it is also important to moisturize afterwards. but then again if it s a damn if you do and damn if you dont. the moisturizer is also an agent to collect more germs. but as much as i wash my hands, (about 200 times a shift), i have to protect the tools that allow me to do my job.

Jessica 9-23-2007 @ 5:10AM

I hav called the hand sanitizer company purell because their labeled not for internal use and yet they tell parents to buy and donate it to their childs school. I found out alot of schools have stopped allowing kids to wash their hands before lunch and put that junk there in their hands knowing kids stick their hands in their mouths especially when they eat. I had to personally tell the school and their teachers each year my children weren't allowed to. What did Purell say about their hand sanitizer being used in that way.... "we do not recommend that type of use" Did their commercials change in the last 2 school years since they were informed NOOOOO. These chemicals could cause new cancers or lifelong illnesses who knows? but please lets worry about a soap. I wouldn't buy it anyway because it obviously leaves a long standing residue that will make your kid sick GOOD LUCK

KMF 9-23-2007 @ 6:13AM

To wrestlersmom, children have indeed actually gotten alcohol poisoning from hand santitizers. I have seen two reports where it was too much sanitizer and not enough supervision at school, the children given a big squirt of the stuff in their hands, being attracted to the rather lemony smell, they didn't rub it onto their hands they ate it.

I'm not a fan of the stuff, I wash my hands in natural soap and water instead. I don't get sick either! Our society has gotten way out of control with our germ phobia. And we're using too many freaky chemicals to kill germs ( but we kill the good guys helping our bodies stay well too!)

Your immune system needs to fight off germs now and again so that it doesn't get bored. They've shown that an obssesively overclean envonroment can cause the immune system to get bored with nothing to fight so it turns on itself and allergies are developed. I've noticed the people who come from overclean house always have really bad allergies.

melissa 11-01-2007 @ 2:03PM

At my son's school there is an alcohol-based sanitizer dispenser by the cafeteria which all the kids are supposed to use before lunch. Apparently there is no time to actually wash hands properly after recess. This worries me... I mean in tests for alcohol (eTg they call them), there is no distinction between using Purell or actually consuming alcohol. Surely that suggests our children are absorbing alcohol?

jackie 12-09-2007 @ 1:23PM

Its actually astounding that school administrators are still referring to a 12 year old 'recommendation' from the US Centers for Disease Control in the course of their promoting alcohol-based gels as an alternative to washing with soap and water. OK, the US Poison Control report linking 12,000 cases of child-related alcohol poisoning didn't impress these schools...and the fact that teens are using Purell as a cocktail ingredient, and as a pyrotechnic device isn't resonating either. What about the fact that alcohol-based gels introduce risk of infection when being applied to cuts/abrasions. What about the fact that alcohol-based hand sanitizers not only lead to dry irritated skin, but stop working immediately after being applied. OK, Purell and others kill germs--ask any hospital administrator to find out that alcohol-based hand sanitizers also kill industrial floor wax. Is this what we want to put on our kids hands??? Great blog at http://www.handhygienefacts.blogspot.com More than a few posts referencing alcohol-free hand sanitizers, including those from Canada's http://www.soapopular.com