Cold Zone Pain Relieving Gel- Dg Health

Description

Cold Zone Pain Relieving Gel, marketed under the DG Health brand, is formulated to provide targeted relief from pain. The product is designed for topical application and is intended for use in managing discomfort associated with various conditions. The effective date of this formulation is 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 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 are advised to stop 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. It is recommended that individuals with sensitive skin 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 combination may lead to altered absorption or increased risk of adverse effects due to overlapping ingredients or mechanisms of action.

Additionally, the use of heating pads or devices in conjunction with this medication is not recommended. The application of heat may enhance the absorption of the drug, potentially leading to increased systemic exposure and heightened risk of side effects.

It is advised that healthcare professionals monitor patients for any signs of adverse reactions when this medication is used, ensuring that it is applied in accordance with the recommended guidelines.

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, without the 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 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 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 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 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care should be maintained until the patient is stabilized and any potential complications are addressed.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any interventions performed, is vital for ongoing patient management and future reference.

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 compound in these areas.

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 inform patients to avoid contact with the eyes and 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. Patients should be cautioned against applying the product to irritated skin or if excessive irritation develops, and they should refrain from bandaging the area after application. It is also essential to remind patients to wash their hands with cool water after use and to avoid using the product with heating pads or devices.

Additionally, 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

Patients should be advised that the medication is for external use only and is to be applied topically. For adults and children aged 2 years and older, a thin film should be rubbed over the affected areas no more than four times daily, without the need for massage. For children under 2 years of age, consultation with a physician is recommended.

Clinicians should counsel patients on safety precautions, including keeping the product away from excessive heat or open flames due to its flammability. 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 medication in conjunction with other topical products or to bandage the area after application. Patients should wash their hands with cool water after use 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 then recur. Pregnant or breastfeeding individuals should seek advice from a health professional before use, and the product should be kept out of reach of children. In case of accidental ingestion, medical help or contact with a Poison Control Center is necessary.

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)