Ultra Strength Pain Relief Gel

Description

Hempvana Brand Ultra Strength Pain Relief Lotion is formulated to provide effective pain relief through the inclusion of menthol at a concentration of 8%. This product features five deep massaging stainless steel rollerballs designed to enhance the application process. Additionally, the formulation incorporates hemp seed oil, which serves to moisturize the skin. The lotion is presented in a net weight of 2.5 ounces (71 grams).

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the product to the affected area no more than 3 to 4 times daily. The application should be performed using the roller ball applicator to ensure even distribution and minimize the risk of contamination.

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

Contraindications

The product is contraindicated in the following situations:

• Application to wounds or damaged, broken, or irritated skin is prohibited due to the potential for exacerbating the condition and causing further irritation.

• Contact with eyes or mucous membranes must be avoided to prevent irritation and potential injury.

• Tight bandaging or the application of local heat (such as heating pads) to the area of use is contraindicated, as this may lead to increased absorption and risk of adverse effects.

• Concurrent use with other topical analgesics is not recommended, as this may increase the risk of systemic absorption and potential toxicity.

Warnings and Precautions

For external use only. Individuals with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use to assess the risk of an allergic reaction.

It is imperative to use this product strictly as directed. Healthcare professionals should advise patients to read and adhere to all instructions and warnings provided on the label. Patients should avoid tightly bandaging the area of application or applying local heat, such as heating pads, to the treated area. Care should be taken to prevent contact with the eyes or mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin. Concurrent use with other topical analgesics is not recommended.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if redness or irritation develops at the site of application.

This product should be kept 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 of several important warnings and precautions. This product 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.

When utilizing 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 crucial 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. The presence of redness or the development of irritation also necessitates stopping use and consulting a healthcare provider.

Additional considerations include the need for pregnant or breastfeeding individuals to consult a health professional before using this product. It is essential to keep the product out of reach of children and pets; in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

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 optimize treatment efficacy. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern about inadvertent overlap in therapy.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily using the roller ball applicator. For children under 2 years of age, it is advised to consult a physician prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis. These events have been documented in the context of routine pharmacovigilance activities.

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 its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older, utilizing a roller ball applicator. For children under 2 years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)