Hempvana Cold as Ice Gel

Description

This product is distributed by Telebrands Corp., located at 79 Two Bridges Road, Fairfield, NJ 07004. It does not contain nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen, aspirin, or salicylate. For additional information, please visit www.hempvana.com or contact customer service at (855) 877-4503, available Monday through Friday from 9 AM to 5 PM EST.

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

The recommended dosage for adults is to apply the product to the affected area no 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 to determine the appropriate course of action.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, use in large quantities, particularly over raw surfaces or blistered areas, is contraindicated to prevent exacerbation of skin conditions. It is also advised not to bandage tightly, as this may lead to compromised circulation or increased local irritation.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should be kept away from excessive heat or open flame to prevent fire hazards.

When applying this product, it is crucial to avoid contact with the eyes. It should not be applied to wounds or damaged skin, and caution is advised against using large quantities, particularly over raw surfaces or blistered areas. Additionally, bandaging should not be done tightly to allow for proper ventilation and to avoid further irritation.

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 clear up and then recur within a few days.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For individuals who are pregnant or nursing, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

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 and refrain from applying it to wounds or damaged skin. It is advised not to use the product in large quantities, particularly over raw surfaces or blistered areas, and to avoid tight bandaging of the area where the product is applied.

Patients are instructed to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, this product should be kept out of reach of children. In the event that the product is swallowed, medical help should be sought immediately or a Poison Control Center should be contacted.

For those who are pregnant or nursing, it is recommended to consult a healthcare professional before using this product to ensure safety for both the patient and the child.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. 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 Gel (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 potential risks associated with this population when determining treatment options.

Geriatric Use

There is no specific information available 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.

Pregnancy

Pregnant patients and nursing mothers are advised to consult a healthcare professional prior to using this medication. The potential risks and benefits should be carefully considered, as the effects on fetal outcomes and nursing infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare 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 nursing mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert text. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment and monitoring.

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 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. It is recommended that healthcare providers assess the patient's condition and consider the necessity of supportive care or specific interventions based on the severity of symptoms presented.

Monitoring and management of the patient should be conducted in a clinical setting, where appropriate measures can be taken to address 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. 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.

While using the product, patients must be cautioned to avoid contact with their eyes. They should not apply the product to wounds or damaged skin and should refrain from using it in large quantities, especially over raw surfaces or blistered areas. Additionally, patients should be advised against tightly bandaging the area where the product is applied.

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 optimal conditions. Proper storage is essential to preserve the quality and efficacy of the product.

Additional Clinical Information

Patients should apply the medication to the affected area no more than 3 to 4 times daily. Clinicians are advised to consult a physician for patients under 18 years of age. Additionally, it is recommended that pregnant or nursing patients seek guidance from a healthcare professional prior to use.

Drug Information (PDF)

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

View product document (PDF)