Hempvana Cold as Ice

Description

Hempvana Roll On is a topical formulation designed for localized application. It contains a proprietary blend of hemp-derived ingredients. The product is presented in a convenient roll-on dosage form, facilitating ease of use. The appearance of the formulation is a clear liquid, allowing for straightforward application to the skin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults, the recommended application is to the affected area not more than 3 to 4 times daily. In the event that the product comes into contact with the hands, it is advised to wash the hands thoroughly with soap and water.

For children under 18 years of age, it is essential to consult a physician prior to use.

Contraindications

Use is contraindicated in the following situations:

Application in large quantities, particularly over raw surfaces or blistered areas, is not recommended due to the potential for increased irritation and adverse effects. The product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to infection. Additionally, tight bandaging is contraindicated, as it may restrict circulation and cause further complications.

Contact with the eyes must be avoided to prevent irritation or injury.

Warnings and Precautions

This product is intended for external use only. It is important to note that the product is flammable; therefore, it should be kept away from excessive heat or open flames to prevent any fire hazards.

When utilizing this product, users should take care to avoid contact with the eyes. In the event of accidental eye contact, immediate rinsing with water is recommended.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure appropriate medical evaluation and intervention if necessary.

Additionally, this product must be kept out of reach of children. In the case of ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately to ensure prompt and effective treatment.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

When using this product, patients should avoid contact with the eyes. It is advised not to use the product in large quantities, particularly over raw surfaces or blistered areas, and it should not be applied to wounds or damaged skin. Additionally, patients should refrain from bandaging the area tightly after application.

Patients are instructed to stop using the product and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Furthermore, this product should be kept out of reach of children. In the event that the product is swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Hempvana Cold as Ice (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 18 years of age should be evaluated by a physician prior to use. It is essential to consider the specific needs and conditions of this population to ensure appropriate care and treatment.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that there is no specific information regarding the use of this product during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the product 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 product and the amount ingested; therefore, a thorough assessment by a medical professional is recommended.

Management of overdosage should be guided by the clinical presentation and may involve supportive care and symptomatic treatment as necessary. It is imperative that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the patient's condition.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to use the product in large quantities, especially over raw surfaces or blistered areas, and to avoid applying it to wounds or damaged skin. It is important to inform patients that they should not bandage the area tightly after application.

Healthcare providers should counsel patients to stop using the product and consult a doctor if their condition worsens. Additionally, patients should be advised to seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Finally, patients should be reminded to avoid contact with their eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in a tightly closed container to ensure its integrity. It should be stored in a cool, dry place to maintain its efficacy and stability. Proper storage conditions are essential to prevent degradation and ensure optimal performance.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults to the affected area. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hempvana Cold as Ice, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)