Cold Zone Pain Relieving Gel- Dg Health

Description

Cold Zone Pain Relieving Gel, marketed under the DG Health brand, is formulated for topical application to provide localized pain relief. The product is designed to deliver effective results as of the effective date, January 23, 2018.

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.

Limitations of Use: There are no known 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 that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur. Monitoring of the patient's condition is essential to ensure appropriate management and to prevent potential complications.

Side Effects

For external use only. Patients should 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 recur. Individuals with sensitive skin are advised to seek medical advice before using this 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.

Monitoring for any signs of adverse reactions is advised when using this medication, particularly in the context of its application with other topical agents or heat sources.

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 aged 2 years and older may apply a thin film of the medication over affected areas up to four times daily, with no need for massage. For children under 2 years of age, consultation with a physician is advised prior to use.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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 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 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 lactating individuals.

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 and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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, and patients should wash their hands with cool water after use. They should also be advised not to use the product with a heating pad or any heating device.

Furthermore, healthcare providers should 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 avoid contact with eyes and mucous membranes, and the product should not be applied to wounds, damaged, or irritated skin. It is important not to use the product in conjunction with other ointments, creams, sprays, or liniments, and bandaging is not recommended. Patients should wash their hands with cool water after application and refrain from using heating pads or devices. They should discontinue use and consult a doctor if the condition worsens, symptoms persist beyond 7 days, or if symptoms clear up and recur. Pregnant or breastfeeding individuals should seek advice from a health professional before use. The product should be kept out of reach of children, and in case of accidental ingestion, medical help or contact with a Poison Control Center is essential.

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)