Dg Health Cold N Hot Pain Relieving

Description

Cold'n Hot is a pain relieving liquid formulated with 16% menthol as the active ingredient. This product is presented in a volume of 2.5 fluid ounces (74 mL). It is characterized by its powerful, fast-acting efficacy in providing pain relief. The formulation features a no-mess applicator, ensuring ease of use, and is designed to be stain-free, making it suitable for application without concern for residue on clothing or surfaces.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and older should apply the medication generously to the affected area. The application should be followed by massaging the product into the painful area until it is thoroughly absorbed into the skin. This process may be repeated if necessary, but should not exceed 3 to 4 times daily. In the event that the medicine comes into contact with hands, it is important to wash hands thoroughly with soap and water.

For children under 12 years of age, it is advised to consult a doctor before use.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for irritation or adverse reactions. Additionally, tight bandaging is not recommended, as it may impede 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, this product should be tested on a small patch of skin prior to generous application to ensure no adverse reactions occur. It is imperative to use the product strictly as directed to avoid complications.

Contact with the eyes and mucous membranes must be avoided to prevent irritation. The product should not be applied to wounds or damaged skin, and care should be taken to avoid tight bandaging of the area where the product is applied. Additionally, the use of heating pads or other heating devices in conjunction with this product is contraindicated.

In the event of redness or skin irritation, the use of the product should be discontinued immediately, and a healthcare professional should be consulted. Users may experience a transient burning sensation upon application; however, this typically resolves within several days. Should the condition worsen, or if symptoms persist for more than 7 days or recur shortly after resolution, it is essential to stop use and seek medical advice.

This product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware that it is intended for external use only. Prior to extensive application, it is recommended to conduct a patch test on a small area of skin to assess for any adverse reactions.

During the use of this product, some patients may experience a transient burning sensation upon application; however, this sensation typically resolves within several days. If redness or skin irritation occurs, patients are advised to discontinue use and consult a healthcare professional.

Patients should also stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days.

It is crucial 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.

Drug Interactions

The use of this medication is contraindicated with heating pads or other heating devices, as the combination may lead to adverse effects.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not necessary.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 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 prescribing information 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 absence of data limits the ability to make informed decisions about dosing and monitoring in this population.

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, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and available guidelines.

Healthcare providers are encouraged to monitor the patient closely and provide supportive care as necessary. This may include symptomatic treatment and, if indicated, specific antidotes or interventions based on the substance involved in the overdosage.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. A transient burning sensation may occur upon application; however, this effect typically resolves within several days. No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided in the context of animal pharmacology and toxicology.

Postmarketing Experience

A transient burning sensation has been reported upon application of the product; however, this sensation typically resolves within several days. This event has been documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, patients must use it only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin. It is important to advise patients against bandaging the area tightly and to refrain from using the product in conjunction with heating pads or other heating devices.

Patients should be made aware that if redness is present, they should discontinue use and consult a doctor. Additionally, if skin irritation occurs, they should stop using the product. A transient burning sensation may occur upon application; however, this sensation generally disappears within several days.

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 at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The product is administered topically, with patients advised to apply it generously to the affected area and massage it into the skin until fully absorbed. This application may be repeated if necessary, but should not exceed 3 to 4 times daily.

Clinicians should counsel patients that the product is for external use only and recommend testing on a small patch of skin prior to full application. Pregnant or breastfeeding patients should consult a healthcare professional before use. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary. Patients should discontinue use and consult a doctor if redness or skin irritation occurs. A transient burning sensation may be experienced upon application, which typically resolves within several days.

Drug Information (PDF)

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

View product document (PDF)