elixicure cbd roll on

Elixicure cbd roll on

– For External Use Only.
– Avoid contact with eyes and mucous membranes.

Active Ingredients
– Hemp Extract 100mg
– Menthol USP Topical Analgesic
– Willow Bark Extract Topical Analgesic

Recommended Uses
– Temporarily relieves minor aches and pains associated with: Sore Muscles and Joints, Strains, Bruises, Sprains, Aches, and Arthritis.

Elixicure’s Pain Relief Roll On is specially formulated using extract of the hemp plant. Our Pain Roll On includes over 90% certified organic ingredients.

Elixicure utilizes the purest, organically derived essential oils and active ingredients to create products that are superior to quality than those available in the marketplace today.

Do Not Use
– On open wounds or damaged skin.
– With a heating pad.
– Do not use before a hot shower or apply hot water after application of cream.
– If you have a Sensitivity to aspirin: People with ASTHMA, STOMACH ULCERS, DIABETES, GOUT, HEMOPHILIA, HYPOPROTHROMBINEMIA, or KIDNEY or LIVER DISEASE might be sensitive to aspirin and also willow bark. – With medications that slow clotting. Medications that slow blood clotting (Anticoagulant / Antiplatelet drugs) can interacts negatively with WILLOW BARK.
– If you are allergic to any listed ingredients.
– Do not bandage tightly.
– Immediately stop usage and consult your physician if you experience any adverse reactions.
anthan Gum, Apricot Kernel Oil, Phenoxyethanol.

Elixicure cbd roll on

Provides Fast-acting Relief

Ease your aches and pains with our wholesome natural pain relief formula. Ideal for strains, sprains, and other chronic pains, it temporarily relieves nagging body pains upon application.

Let nature help you function like you used to with Elixicure. Plant-based and all-natural, our Pain Relief Cream helps soothe stubborn body pains to improve your quality of life.

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This potent formulation uses plant-based ingredients that are safe for all skin types, including:

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address these violations within 15 working days, state your reasons for delay and your schedule for completion.

Current Good Manufacturing Practice (CGMP) Charges

If you have any questions regarding this letter, please contact LCDR Rumany Penn, Compliance Officer, at 301-633-6789, or by email at [email protected]

New drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless they are nonprescription drugs governed by and lawfully marketed under section 505G 2 of the FD&C Act, among other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for any of these external analgesic products, nor do they meet the requirements for marketing without an approved application under section 505G of the FD&C Act, as described below. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

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Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and ensure the quality of raw material inputs, in-process materials, and finished drugs. Failure to conduct these studies can result in product quality attribute failures. Process qualification studies determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.

Your firm failed to adequately qualify the equipment and validate the processes used to manufacture your drug products. You have not performed process performance qualification (PPQ) studies, nor do you have an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality for products in U.S. distribution.

CDR Steven E. Porter, Jr
Director, Division of Pharmaceutical Quality Operations IV

Furthermore, even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements for nonprescription drug products under section 505G of the FD&C Act. In particular, such product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e).

Additionally, in your response, you designated (b)(4) to execute the independent Quality Assurance (QA) functions of the organization and committed to revise applicable procedures to reflect QA’s oversight responsibilities. However, the revised QA procedures you proposed only pertain to who is allowed to render final quality decisions. You have not proposed new or revised procedures that govern other deficient aspects of your QU, such as investigating deviations, developing corrective actions and preventive actions, implementing change controls, and auditing component suppliers’ test results.

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