Hempvana Cold as Ice

Description

Hempvana Menthol Patch is a topical formulation designed for localized pain relief. The patch contains menthol as its active ingredient, which provides a cooling sensation upon application. It is intended for use on the skin and is characterized by its adhesive backing, allowing for secure placement on the affected area. The patch is designed to deliver menthol over an extended period, facilitating sustained relief from discomfort. The product is presented in a convenient dosage form, suitable for various applications in pain management.

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 over 12 years of age, the affected area should be cleaned and dried prior to application. One patch should be applied to the affected area, adhering to the application instructions provided. The patch may be applied no more than 3 to 4 times daily. It is important to remove the patch from the affected area after a maximum application duration of 8 hours.

For children under 12 years of age, it is recommended to consult a healthcare professional before use.

Contraindications

Use is contraindicated in patients with a known allergy to menthol or any inactive ingredients. The product should not be used if the package is damaged or opened, as this may compromise safety and efficacy.

Additionally, the application of more than one patch at a time is contraindicated. The product must not be applied to wounds, cuts, damaged, broken, or irritated skin, nor should it be used over raw surfaces or blistered areas. Concurrent use with other topical analgesics is also contraindicated to avoid potential adverse effects.

Warnings and Precautions

For external use only. The application of this product is strictly limited to the skin surface and should not be used in any other manner.

The following precautions must be observed to ensure safe use of the product:

Contraindications This product should not be applied in the following circumstances:

• More than one patch should not be used simultaneously.

• It must not be applied to wounds, cuts, damaged, broken, or irritated skin.

• Avoid application over raw surfaces or blistered areas.

• Concurrent use with other topical analgesics is prohibited.

• Individuals with known allergies to menthol or any of the inactive ingredients should refrain from use.

• The product should not be used if the package is damaged or opened.

Monitoring and Discontinuation Users are advised to stop use and consult a healthcare professional if any of the following occur:

• The condition worsens.

• Symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

• Redness or irritation develops at the application site.

Emergency Situations In the event of ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated to apply more than one patch at a time, on wounds, cuts, damaged, broken, or irritated skin, over raw surfaces or blistered areas, or concurrently with other topical analgesics. Additionally, individuals who are allergic to menthol or any inactive ingredients should not use this product. The packaging should be intact; if the package is damaged or opened, the product should not be used.

While using this product, patients are advised to follow all directions and warnings as indicated on the label. It is important not to bandage the area tightly or apply local heat, such as heating pads, to the site of application. Care should be taken to avoid contact with the eyes or mucous membranes.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The presence of redness or the development of irritation also warrants cessation of use and consultation with a doctor.

Additional considerations include consulting a healthcare professional if pregnant or breastfeeding. The product should be kept out of reach of children and pets; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

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

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 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended application involves cleaning and drying the affected area, followed by the application of one patch. This patch may be applied no more than 3 to 4 times daily, with a maximum wear time of 8 hours per application.

It is essential to keep the product out of reach of children and pets. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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. 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 drug 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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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. Healthcare professionals are advised to seek medical help or contact a Poison Control Center without delay if an overdose is suspected.

Symptoms of overdosage may vary depending on the substance involved and the amount ingested. It is essential for healthcare providers to monitor the patient closely for any signs of adverse reactions or complications that may arise from the overdose.

Management of overdosage should be guided by the specific circumstances of the case, including the substance involved and the patient's clinical status. Prompt intervention and supportive care are critical in mitigating potential risks associated with 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 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 the medication out of reach of children and pets. In the event of ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients must be instructed to use the medication only as directed. It is essential for them to read and follow all directions and warnings provided on the label to ensure safe and effective use.

Providers should inform patients not to bandage the area of application tightly or apply local heat, such as heating pads, to the site of use, as this may lead to adverse effects.

Additionally, patients should be cautioned to avoid contact with their eyes or mucous membranes to prevent irritation or injury.

Storage and Handling

The patches should be stored in a cool, dry place, away from direct sunlight to maintain their integrity. It is essential to protect the patches from excessive moisture to ensure their effectiveness. Proper storage conditions will help preserve the quality of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically, with a recommended application of one patch to the affected area no more than 3-4 times daily. Each patch should be removed after a maximum application time of 8 hours.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Additionally, it is important to keep the product out of reach of children and pets; in the event of ingestion, medical assistance or contact with a Poison Control Center is advised.

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)