Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis

Description

Hempvana Ultra Strength is a topical gel formulated for pain relief, specifically targeting arthritis discomfort. The product contains 8% menthol, which provides a cooling sensation to alleviate pain. It is enhanced with four times the amount of hemp seed oil, contributing to moisturization of the skin. The gel is presented in a platinum formulation and is packaged in a net weight of 3 ounces (85 grams).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. It is intended for use in patients experiencing discomfort due to minor injuries or overexertion.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

The product is contraindicated in the following situations:

• Tight bandaging or the application of local heat (e.g., heating pads) to the area of use is not recommended, as this may exacerbate adverse effects.

• Contact with eyes or mucous membranes should be avoided to prevent irritation or injury.

• Application to wounds or damaged, broken, or irritated skin is contraindicated due to the potential for increased sensitivity or adverse reactions.

• Concurrent use with other topical analgesics is not advised, as this may lead to enhanced side effects or reduced efficacy.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a known allergy to aspirin or salicylates.

When utilizing this product, it is imperative to adhere strictly to the provided instructions. Patients must read and follow all directions and warnings indicated on the label. It is essential to avoid bandaging the area tightly or applying local heat, such as heating pads, to the site of application. Additionally, contact with the eyes or mucous membranes should be avoided, and the product must not be applied to wounds or areas of damaged, broken, or irritated skin. Concurrent use with other topical analgesics is contraindicated.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist beyond 7 days, or symptoms resolve and then recur within a few days. The presence of redness or the development of irritation also necessitates cessation of use and consultation with a healthcare provider.

It is crucial to keep this product out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use.

While using this product, patients should avoid bandaging the area tightly or applying local heat, such as heating pads, to the site of application. It is also important to prevent contact with the eyes or mucous membranes and to refrain from applying the product to wounds or areas of damaged, broken, or irritated skin. Concurrent use with other topical analgesics is not recommended.

Patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, if redness or irritation develops, patients should stop using the product and consult a healthcare provider.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimal therapeutic outcomes. Monitoring for signs of increased local irritation or systemic effects is recommended if there is any uncertainty regarding the use of concomitant topical treatments.

Packaging & NDC

Below are the non-prescription pack sizes of Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis (menthol 8%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and pets to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, they should seek medical advice if they notice any redness or if irritation develops.

When using this product, patients must be reminded to use it only as directed and to read and follow all directions and warnings on the label carefully. They should avoid bandaging the area tightly or applying local heat, such as heating pads, to the site of application. It is also important to instruct patients to avoid contact with their eyes or mucous membranes and not to apply the product to wounds or damaged, broken, or irritated skin. Furthermore, patients should be cautioned against using this product simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)