Consumer Protection Law

Consumer Protection Law Questions? Ask a Lawyer Now.

Ask a Lawyer,
Get an Answer ASAP!

Consumer Protection Law

WHAT ARE THE REQUIREMENTS FOR PACKAGING OF ANY % OF

Customer Question
LIDOCAINE IN A OTC PRODUCT...
WHAT ARE THE REQUIREMENTS FOR PACKAGING OF ANY % OF LIDOCAINE IN A OTC PRODUCT? I WOULD LIKE TO KNOW ALSO WHAT DOES THE LABEL ON A 5% OTC LIDOCAINE PRODUCT HAVE TO SAY IN REGARDS ***** ***** THE PRODUCT CAN BE USED FOR?
Submitted: 2 months ago.Category: Consumer Protection Law
Show More
Show Less
Ask Your Own Consumer Protection Law Question
Answered in 1 day by:
12/20/2017
Consumer Protection Lawyer: Law Educator, Esq., Lawyer replied 2 months ago
Law Educator, Esq.
Category: Consumer Protection Law
Satisfied Customers: 121,842
Experience: Attorney experienced in commercial litigation.
Verified

Thank you for your question. I look forward to working with you to provide you the information you are seeking for educational purposes only. Please feel free to ignore any phone service request, the expert does not send those unless asked by customer and they are sent by the site automatically.

Products that contain 5% Lidocaine or more in a single package must follow the following packaging guidelines set forth in 16 CFR 1700.15(a) and (b).

The CFR says as follows:

(a)General requirements. The special packaging must continue to function with the effectiveness specifications set forth in paragraph (b) of this section when in actual contact with the substance contained therein. This requirement may be satisfied by appropriate scientific evaluation of the compatibility of the substance with the special packaging to determine that the chemical and physical characteristics of the substance will not compromise or interfere with the proper functioning of the special packaging. The special packaging must also continue to function with the effectiveness specifications set forth in paragraph (b) of this section for the number of openings and closings customary for its size and contents. This requirement may be satisfied by appropriate technical evaluation based on physical wear and stress factors, force required for activation, and other such relevant factors which establish that, for the duration of normal use, the effectiveness specifications of the packaging would not be expected to lessen.

(b)Effectiveness specifications. Special packaging, tested by the method described in § 1700.20, shall meet the following specifications:

(1) Child-resistant effectiveness of not less than 85 percent without a demonstration and not less than 80 percent after a demonstration of the proper means of opening such special packaging. In the case of unit packaging, child-resistant effectiveness of not less than 80 percent.

(2)Ease of adult opening -

(i)Senior-adult test. Except for products specified in paragraph (b)(2)(ii) of this section, special packaging shall have a senior adult use effectiveness (SAUE) of not less than 90% for the senior-adult panel test of § 1700.20(a)(3).

(ii)Younger-adult test -

(A)When applicable. Products that must be in aerosol form and products that require metal containers, under the criteria specified below, shall have an effectiveness of not less than 90% for the younger-adult test of § 1700.20(a)(4). The senior-adult panel test of § 1700.20(a)(3) does not apply to these products. For the purposes of this paragraph, metal containers are those that have both a metal package and a recloseable metal closure, and aerosol products are self-contained pressurized products.

(B)Determination of need for metal or aerosol container -

(1)Criteria. A product will be deemed to require metal containers or aerosol form only if:

(i) No other packaging type would comply with other state or Federal regulations,

(ii) No other packaging can reasonably be used for the product's intended application,

(iii) No other packaging or closure material would be compatible with the substance,

(iv) No other suitable packaging type would provide adequate shelf-life for the product's intended use, or

(v) Any other reason clearly demonstrates that such packaging is required.

(2)Presumption. In the absence of convincing evidence to the contrary, a product shall be presumed not to require a metal container if the product, or another product of identical composition, has previously been marketed in packaging using either a nonmetal package or a nonmetal closure.

(3)Justification. A manufacturer or packager of a product that is in a metal container or aerosol form that the manufacturer or packager contends is not required to comply with the SAUE requirements of § 1700.20(a)(3) shall provide, if requested by the Commission's staff, a written explanation of why the product must have a metal container or be an aerosol. Manufacturers and packagers who wish to do so voluntarily may submit to the Commission's Office of Compliance a rationale for why their product must be in metal containers or be an aerosol. In such cases, the staff will reply to the manufacturer or packager, if requested, stating the staff's views on the adequacy of the rationale.

See: https://www.law.cornell.edu/cfr/text/16/1700.15

The law states it must conform with 21 CFR 201.66, found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.66

You can only make representations in the labeling consistent with the FDA approved uses for lidocaine in accordance with pharmacological descriptions for lidocaine.

Please do not forget to leave positive feedback by clicking on the 5 stars at the top of your page, as the experts are not employees of the site and get no credit for spending time with customers unless they leave positive feedback. Thank you.

Ask Your Own Consumer Protection Law Question
Was this answer helpful?
Ask Law Educator, Esq. Your Own Question
Law Educator, Esq.
Law Educator, Esq.
Law Educator, Esq., Lawyer
Category: Consumer Protection Law
Satisfied Customers: 121,842
121,842 Satisfied Customers
Experience: Attorney experienced in commercial litigation.

Law Educator, Esq. is online now

A new question is answered every 9 seconds

How JustAnswer works:

  • Ask an ExpertExperts are full of valuable knowledge and are ready to help with any question. Credentials confirmed by a Fortune 500 verification firm.
  • Get a Professional AnswerVia email, text message, or notification as you wait on our site. Ask follow up questions if you need to.
  • 100% Satisfaction GuaranteeRate the answer you receive.

JustAnswer in the News:

Ask-a-doc Web sites: If you've got a quick question, you can try to get an answer from sites that say they have various specialists on hand to give quick answers... Justanswer.com.
JustAnswer.com...has seen a spike since October in legal questions from readers about layoffs, unemployment and severance.
Web sites like justanswer.com/legal
...leave nothing to chance.
Traffic on JustAnswer rose 14 percent...and had nearly 400,000 page views in 30 days...inquiries related to stress, high blood pressure, drinking and heart pain jumped 33 percent.
Tory Johnson, GMA Workplace Contributor, discusses work-from-home jobs, such as JustAnswer in which verified Experts answer people’s questions.
I will tell you that...the things you have to go through to be an Expert are quite rigorous.

What Customers are Saying:

Mr. Kaplun clearly had an exceptional understanding of the issue and was able to explain it concisely. I would recommend JustAnswer to anyone. Great service that lives up to its promises!

Gary B.Edmond, OK

My Expert was fast and seemed to have the answer to my taser question at the tips of her fingers. Communication was excellent. I left feeling confident in her answer.

EricRedwood City, CA

I am very pleased with JustAnswer as a place to go for divorce or criminal law knowledge and insight.

MichaelWichita, KS

PaulMJD helped me with questions I had regarding an urgent legal matter. His answers were excellent.

Three H.Houston, TX

Anne was extremely helpful. Her information put me in the right direction for action that kept me legal, possible saving me a ton of money in the future. Thank you again, Anne!!

ElaineAtlanta, GA

It worked great. I had the facts and I presented them to my ex-landlord and she folded and returned my deposit. The 50 bucks I spent with you solved my problem.

TonyApopka, FL

Wonderful service, prompt, efficient, and accurate. Couldn't have asked for more. I cannot thank you enough for your help.

Mary C.Freshfield, Liverpool, UK

< Previous | Next >

Meet the Experts:

Infolawyer

Infolawyer

Lawyer

6,930 satisfied customers

Licensed attorney helping individuals and businesses.

Ely

Ely

Counselor at Law

3,422 satisfied customers

Private practice with focus on family, criminal, PI, consumer protection, and business consultation.

Barrister

Barrister

Lawyer

1,607 satisfied customers

Attorney,17 years experience in consumer protection areas

Tina

Tina

Lawyer

1,587 satisfied customers

17 years legal experience including consumer protection law.

P. Simmons

P. Simmons

Lawyer

1,184 satisfied customers

16+ yrs. of legal experience.

LADY LAWYER

LADY LAWYER

Lawyer

748 satisfied customers

Consumer Lawyer

RGMacEsq

RGMacEsq

Lawyer

582 satisfied customers

Licensed Texas General Practice Attorney

< Previous | Next >

Related Consumer Protection Law Questions
Wishing to import sets of kitchen utensils with silicon
Wishing to import sets of kitchen utensils with silicon heads (eg spatula, spoon) into USA in 2018. As each tool is directly in contact with food would I need to register this product as FDA approved … read more
WiseOwl58
WiseOwl58
JD Honors Graduate
3,830 satisfied customers
WHAT ARE THE REQUIREMENTS FOR PACKAGING OF ANY % OF
WHAT ARE THE REQUIREMENTS FOR PACKAGING OF ANY % OF LIDOCAINE IN A OTC PRODUCT? I WOULD LIKE TO KNOW ALSO WHAT DOES THE LABEL ON A 5% OTC LIDOCAINE PRODUCT HAVE TO SAY IN REGARDS ***** ***** THE PRODU… read more
Law Educator, Esq.
Law Educator, Esq.
Lawyer
121,842 satisfied customers
I have a nevro spine stilulator in two years, I have had to
I have a nevro spine stilulator in two years, I have had to exchange four battery chargers, for obvious defects. two would not work from the start. they informed me they would no longer give me new on… read more
Phillips Esq.
Phillips Esq.
Attorney-at-Law
JD
18,658 satisfied customers
Remedy for multiple illegal hospitalization in Illinois.
Remedy for multiple illegal hospitalization in Illinois. Page 441 of Case 170P1598 documents that Cigna would not cover incurence that I had to pay! They said I had No Clinical Evidence that Dr Stephe… read more
Law Educator, Esq.
Law Educator, Esq.
Lawyer
121,842 satisfied customers
I would like to know if I can sue a company for false
I would like to know if I can sue a company for false advertising. There is blatant false advertising where the company makes claims that the product is 100% effective. And they Make claims that the p… read more
Infolawyer
Infolawyer
Lawyer
Doctoral Degree
6,930 satisfied customers
There is a large group of woman who have been injured by a
There is a large group of woman who have been injured by a product. We have started a private Facebook group to organize and launch a class action lawsuit. The owner of the product has committed fraud… read more
Law Educator, Esq.
Law Educator, Esq.
Lawyer
121,842 satisfied customers
I have a Class III FDA approved medical device. If I start
I have a Class III FDA approved medical device. If I start replacing components of this equipment with after-market, non-OEM approved parts, will this affect the original FDA approval status? Also, co… read more
Phillips Esq.
Phillips Esq.
Attorney-at-Law
JD
18,658 satisfied customers
I am creating my own dietary supplement products. The
I am creating my own dietary supplement products. The products will be sold in their individual carton boxes. The question is this: Since the product bottle is very very small I have very limited spac… read more
KLAW
KLAW
Juris Doctorate
1,848 satisfied customers
My medicare drug insurance plan says that Adderall is not
My medicare drug insurance plan says that Adderall is not FDA approved for the medical condition Hypersomnia. … read more
Phillips Esq.
Phillips Esq.
Attorney-at-Law
JD
18,658 satisfied customers
In Illinois a doctor prescribed a medication to me that is
In Illinois a doctor prescribed a medication to me that is not legal in the US. The FDA allows it in some cases only after rigorous screening and monitering. My doctor never even notified or applied t… read more
Phillips Esq.
Phillips Esq.
Attorney-at-Law
JD
18,658 satisfied customers
I have Interstial cystitis, am 61, after years of doing
I have Interstial cystitis , am 61 , after years of doing painful treatments without success My PCp and I made the difficult decision that I needed to take a moderate dose of a narcotic as we had exha… read more
Dwayne B.
Dwayne B.
Juris Doctor
28,764 satisfied customers
I've got a startup that sells supplements online - an
I've got a startup that sells supplements online - an "e-commerce supplement company" And am wondering 1. what are some generic warnings/disclaimers that are necessary to 'cover my ass'? 2. should i h… read more
Law Educator, Esq.
Law Educator, Esq.
Lawyer
121,842 satisfied customers
I'm a food labeling compliance specialist and I'm trying to
Hi Pearl.... I'm a food labeling compliance specialist and I'm trying to find where the FDA allows for herb ingredients in a product to be listed as "herbs" instead of spices (as per 21cfr101.22). Do … read more
Marsha411JD
Marsha411JD
Doctoral Degree
20,289 satisfied customers
I am wondering if physicians manage the health care industry
I am wondering if physicians manage the health care industry or attorneys do. No offense meant to your profession. My PCP gave me a printout by Drugs.com that stated a recommended 3200mg of a medicati… read more
Law Educator, Esq.
Law Educator, Esq.
Lawyer
121,842 satisfied customers
I am a small E Liquid Manufacturer. The new child resistant
Hello. I am a small E Liquid Manufacturer. The new child resistant closure law took effect 7/26/2017. The code is 16 C.F.R. 1700.15 1700.20. I'm trying to make sure I am in compliance. I have the cert… read more
Infolawyer
Infolawyer
Lawyer
Doctoral Degree
6,930 satisfied customers
Is it legal to market hormone replacement therapy online? If
Is it legal to market hormone replacement therapy online? If so, where can I find the guidelines as to what is / isn't allowed? I've been asked to help a few of these clinics with marketing testostero… read more
Attyadvisor
Attyadvisor
Doctoral Degree
7,335 satisfied customers
Do the US customs officials look the other way on all dugs
Do the US customs officials look the other way on all dugs other than illegal drugs of course I figure Opiates and things like Amphetamines along with Steroids don't get the 90 day personal use treatm… read more
LegalGems
LegalGems
Juris Doctorate
11,031 satisfied customers
How do I go about getting my money back. In September of 2013
How do I go about getting my money back. In September of 2013 I ordered a Thermal Massage Bed and a Feet Massager from Camex Wellness Limited in India, after I was assured that they were permitted to … read more
Infolawyer
Infolawyer
Lawyer
Doctoral Degree
6,930 satisfied customers

DISCLAIMER: Answers from Experts on JustAnswer are not substitutes for the advice of an attorney. JustAnswer is a public forum and questions and responses are not private or confidential or protected by the attorney-client privilege. The Expert above is not your attorney, and the response above is not legal advice. You should not read this response to propose specific action or address specific circumstances, but only to give you a sense of general principles of law that might affect the situation you describe. Application of these general principles to particular circumstances must be done by a lawyer who has spoken with you in confidence, learned all relevant information, and explored various options. Before acting on these general principles, you should hire a lawyer licensed to practice law in the jurisdiction to which your question pertains.

The responses above are from individual Experts, not JustAnswer. The site and services are provided “as is”. To view the verified credential of an Expert, click on the “Verified” symbol in the Expert’s profile. This site is not for emergency questions which should be directed immediately by telephone or in-person to qualified professionals. Please carefully read the Terms of Service (last updated February 8, 2012).

DISCLAIMER: Answers from Experts on JustAnswer are not substitutes for the advice of an attorney. JustAnswer is a public forum and questions and responses are not private or confidential or protected by the attorney-client privilege. The Expert above is not your attorney, and the response above is not legal advice. You should not read this response to propose specific action or address specific circumstances, but only to give you a sense of general principles of law that might affect the situation you describe. Application of these general principles to particular circumstances must be done by a lawyer who has spoken with you in confidence, learned all relevant information, and explored various options. Before acting on these general principles, you should hire a lawyer licensed to practice law in the jurisdiction to which your question pertains.

The responses above are from individual Experts, not JustAnswer. The site and services are provided “as is”. To view the verified credential of an Expert, click on the “Verified” symbol in the Expert’s profile. This site is not for emergency questions which should be directed immediately by telephone or in-person to qualified professionals. Please carefully read the Terms of Service (last updated February 8, 2012).

Show MoreShow Less

Ask Your Question

x