Dermachange Cold Therapy

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description section.

Uses and Indications

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

Limitations of Use: This medication is intended for short-term use and should not be used as a substitute for more comprehensive pain management strategies in chronic conditions.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

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

Contraindications

There are no contraindications listed for this product. However, in the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. This product should not be used in conjunction with other topical pain relievers, nor should it be applied while using heating pads or other heating devices, as this may increase the risk of adverse effects.

Care should be taken to avoid contact with the eyes; the product must not be applied to wounds or damaged skin. Additionally, it is advised not to bandage the area tightly after application, as this may lead to increased absorption and potential toxicity.

If the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear and then recur within a few days, the user should discontinue use and consult a healthcare professional for further evaluation.

In the event of accidental ingestion, immediate medical assistance should be sought, or the user should contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in conjunction with other topical pain relievers, as well as with heating pads or heating devices, due to the potential for increased adverse effects.

Participants are advised against applying the product in or near the eyes, on wounds, or on damaged skin. Additionally, it is important not to bandage the area tightly after application.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients should discontinue use and consult a healthcare professional.

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated due to the potential for increased local irritation or adverse effects. It is essential to avoid using this medication in conjunction with heating pads or other heating devices, as this may enhance the risk of skin irritation or burns.

Monitoring for signs of adverse reactions is advised when this medication is used, particularly in patients who may be using other topical agents or heat sources concurrently.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of Dermachange Cold Therapy Gel in lactating mothers. Additionally, there are no statements concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants during the use of this product while nursing.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial 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 question.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients that if the product is swallowed, it is crucial to seek medical help immediately or contact a Poison Control Center. This information is essential for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

For adults and children aged 12 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years old, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)