Cold Zone Pain Relieving Gel- Dg Health

Description

Cold Zone Pain Relieving Gel by DG Health is presented in a bulk dosage form. The product is designed for topical application and is packaged in a 2 fluid ounce container. The effective date of this formulation is July 18, 2018. The observation media includes an image of the shipper label, which is available in JPEG format, identified as DG_Cold Zone Pain Relief Gel_2 fl oz_shipper Label.jpg.

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

Patients should discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur.

General precautions must be observed to ensure safe application. Contact with the eyes or mucous membranes should be strictly avoided. The product should 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 stopped. Bandaging the area after application is not recommended. It is also advised to wash hands thoroughly with cool water after use. The use of heating pads or devices in conjunction with this product is not advised.

No specific laboratory tests are required for the safe use of this product.

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. Additionally, individuals with sensitive skin are advised to seek medical advice before using this product.

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 products 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.

It is advised to monitor for any signs of irritation or adverse reactions when using this medication, and to avoid concurrent use with the aforementioned products to ensure optimal therapeutic outcomes.

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

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 potential 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 maternal and fetal safety.

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 medication 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 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 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 these contexts.

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 and 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

Patients aged 2 years and older are advised to apply a thin film of the product 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 recommended prior to use.

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. The product should not be applied to wounds, damaged, or irritated skin, nor should it be used in conjunction with other topical ointments, creams, sprays, or liniments. 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 health professional before use. Additionally, the product should be kept out of reach of children, and in the event of accidental ingestion, medical help or contact with a Poison Control Center should be sought immediately.

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)