Healthwise Soothing Cold Therapy Gel

Description

HealthWise Soothing Cold Therapy Gel contains 4% menthol as its active ingredient. This formulation is designed for topical application, providing a cooling sensation to alleviate discomfort associated with minor aches and pains. The gel is characterized by its clear appearance and is intended for use in various therapeutic contexts.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected area, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with eyes or mucous membranes should be avoided, as it may cause irritation. Application to wounds or damaged skin is not recommended due to the potential for adverse reactions. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, as this may lead to unpredictable effects. Application to irritated skin or in cases where excessive irritation develops is contraindicated. Bandaging the area after application is not advised, nor should the product be used with heating pads or devices, as this may increase the risk of skin irritation or burns.

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 reoccur.

Warnings and Precautions

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

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. During the application of this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, bandaging the area after application is not recommended. It is advised that patients wash their hands with cool water after use and avoid using the product with heating pads or devices.

Patients should be instructed to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only and is flammable; it should be kept away from excessive heat or open flame. Prior to use, individuals with sensitive skin should consult a doctor.

While using this product, patients must avoid contact with eyes or mucous membranes and should not apply it to wounds or damaged skin. It is also advised not to use the product in conjunction with other ointments, creams, sprays, or liniments, and to refrain from applying it to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, and hands should be washed with cool water after use. Additionally, the product should not be used with a heating pad or device.

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 reoccur.

For pregnant or breastfeeding individuals, it is essential to seek advice from a health professional before using this product.

This product should 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 (800-222-1222) is recommended.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this medication is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not necessary in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Healthwise Soothing Cold Therapy Gel (menthol 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the medication over the affected area up to four times daily; massage is not necessary. For children under 2 years of age, consultation with a physician is advised prior to use.

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 maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 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 individuals 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, it is imperative to keep the product out of reach of children. Accidental ingestion can occur, and immediate action is required. Healthcare professionals should advise caregivers to seek medical assistance or contact a Poison Control Center at 800-222-1222 without delay.

Prompt intervention is crucial in managing potential overdosage situations. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. It is essential to follow established protocols for the specific substance involved in the overdosage to ensure optimal patient outcomes.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Patients should be instructed 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 reoccur.

When using this product, patients must avoid contact with their eyes or mucous membranes. They should not apply the product to wounds or damaged skin, nor should they use it in conjunction with other ointments, creams, sprays, or liniments. It is important to avoid application on irritated skin or if excessive irritation develops. Patients should refrain from bandaging the area after application and should wash their hands with cool water following use. Additionally, they should not use the product with a heating pad or any heating device.

Patients with sensitive skin should be encouraged to consult a doctor before using this product.

Storage and Handling

The product is supplied in a tube format. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Healthcare professionals should ensure that the tube seal under the cap is intact before use; the product should not be used if this seal is broken.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)