Cold Zone Pain Relieving Gel- Dg Health

Description

Cold Zone Pain Relieving Gel, marketed under the DG Health brand, is a topical formulation designed for pain relief. The product is intended for external use and is characterized by its gel dosage form. The effective date of this formulation is April 12, 2018. Further details regarding its chemical composition, molecular weight, and inactive ingredients are not provided in the extracted facts.

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 areas, 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 to ensure safety and appropriateness of treatment.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. Application to irritated skin or in cases where excessive irritation develops is contraindicated to prevent further skin damage. Bandaging the area after application is not advised, as it may alter the product's effectiveness. Additionally, the use of heating pads or devices in conjunction with this product is contraindicated due to the risk of increased irritation or adverse reactions.

Warnings and Precautions

For external use only. It is imperative to adhere to the following warnings and precautions to ensure safe and effective use of the product.

General Precautions Healthcare professionals should advise patients to avoid contact with the eyes or mucous membranes. The product must not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and if excessive irritation develops, use should be discontinued. Bandaging the area after application is not recommended. Patients should wash their hands thoroughly with cool water after use to prevent unintended exposure. Additionally, the product should not be used in conjunction with heating pads or devices, as this may lead to adverse effects.

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

Monitoring and Follow-Up Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Regular follow-up is advised to monitor the patient's response to treatment and to address any concerns that may arise during the course of therapy.

Side Effects

For external use only. Patients should be advised 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. Additionally, individuals with sensitive skin are encouraged to seek medical advice before using the product. No specific adverse reactions or side effects have been reported in clinical trials or postmarketing experiences.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to increased risk of adverse effects or reduced efficacy of the treatment.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The combination may enhance local irritation or alter the pharmacological effects of the medication.

Healthcare professionals should ensure that patients are advised against these combinations to maintain the safety and effectiveness of the treatment regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Zone Pain Relieving Gel- Dg Health (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended dosage is to apply a thin film over the affected areas up to four times daily. Massage of the application site is not necessary.

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 elderly patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing treatment in this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

When using this product, it is important to avoid contact with the eyes or mucous membranes. Patients should be cautioned against applying the product to wounds or damaged skin, and they should not use it in conjunction with other ointments, creams, sprays, or liniments. Additionally, patients should refrain from applying the product to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended. Patients should wash their hands with cool water after use and should not use the product with a heating pad or any heating device.

Healthcare providers should also encourage patients to consult a doctor before using the product if they have sensitive skin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, away from excessive heat or open flame to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin film over affected areas for adults and children aged 2 years and older, not exceeding four times daily. For children under 2 years of age, consultation with a physician is advised.

Clinicians should counsel patients on the following precautions: the product is for external use only and is flammable, necessitating avoidance of excessive heat or open flames. Patients should be advised to consult a doctor if they have sensitive skin, and to avoid contact with eyes or mucous membranes. It should not be applied to wounds, damaged, or irritated skin, nor used in conjunction with other topical products. Bandaging the area is not recommended, and hands should be washed with cool water after application. Patients should discontinue use and seek medical advice if their condition worsens, symptoms persist beyond 7 days, or if symptoms clear and then recur. Pregnant or breastfeeding individuals should consult a healthcare professional before use, and the product should be kept out of reach of children, with immediate medical assistance sought in case of accidental ingestion.

Drug Information (PDF)

This file contains official product information for Cold Zone Pain Relieving Gel- Dg Health, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)