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WHAT ARE THE REQUIREMENTS FOR PACKAGING OF ANY % OF

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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: 7 months ago.Category: Consumer Protection Law
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12/20/2017
Consumer Protection Lawyer: Law Educator, Esq., Lawyer replied 7 months ago
Law Educator, Esq.
Category: Consumer Protection Law
Satisfied Customers: 125,846
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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.

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