Dg Health Cold Zone Pain Relieving

Description

DG™|health is a cold zone pain-relieving gel formulated with 4% menthol as a topical analgesic. This product is designed to provide relief from arthritis, backache, muscle pain, and joint pain. It features soothing menthol and is free from parabens. The gel is packaged in a 2 fluid ounce (59 mL) container.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including conditions such as simple backache, arthritis, strains, bruises, and sprains. It is specifically indicated for the management of arthritis, backache, muscle pain, and joint pain.

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

Dosage and Administration

For adults and children aged 6 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 limited to the specified frequency to avoid potential adverse effects.

Children under 6 years of age should not use this product. Healthcare professionals are advised to monitor the application in patients within the approved age range to ensure compliance with the recommended dosing guidelines.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage tightly, as this may restrict circulation and lead to complications. The use of heating pads or other heating devices in conjunction with this product is also contraindicated, as it may increase the risk of skin irritation or burns.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes when using this product. It is imperative that the product is not applied to wounds or damaged skin, and that it is not bandaged tightly. Additionally, the use of heating pads or other heating devices in conjunction with this product is contraindicated.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product is flammable; therefore, it must be kept away from fire or flame. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use to ensure safety.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should not bandage the area tightly or use the product in conjunction with heating pads or other heating devices, as these practices may lead to adverse effects.

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 are advised to stop use and consult a healthcare professional.

This product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use.

To ensure safety, the product should be kept out of reach of children. If the product is swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 years and older, the recommended application is to the affected area not more than 3-4 times daily.

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 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 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. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center at 1-800-222-1222 is recommended for guidance on appropriate actions to take.

It is essential to monitor for potential symptoms of overdosage, which may vary depending on the specific substance involved. Healthcare providers should be prepared to assess the patient for any signs of toxicity and initiate appropriate management procedures based on the clinical presentation.

Prompt intervention and adherence to established protocols are vital in mitigating the effects of an overdosage and ensuring patient safety.

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. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

When using this product, it is important to avoid contact with the eyes. Patients should be cautioned against applying the product to wounds or damaged skin. Additionally, they should not bandage the area tightly and should refrain from using heating pads or other heating devices in conjunction with the product.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. The tube should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, it is advised to discard the product after opening if it is not used within the specified time frame. Care should be taken to keep the product away from fire or flame to ensure safety during storage and handling.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3-4 times daily for adults and children aged 6 years and older. It is contraindicated for use in children under 6 years of age.

Clinicians should counsel patients that the product is for external use only and advise them to discontinue use and consult a doctor if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Patients should be informed that the product is flammable and should be kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought. Additionally, patients should avoid contact with eyes, refrain from applying the product to wounds or damaged skin, and should not use tight bandages or heating devices in conjunction with the product. It is also important to keep the product away from fire or flame. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

Drug Information (PDF)

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

View product document (PDF)