Duane Reade

Description

Placeholder text. DR_hot_and_cold_balm_label is a topical formulation designed for the relief of muscle and joint discomfort. The product is presented in a cream dosage form, characterized by its smooth texture and easy application. The formulation includes a blend of active ingredients that provide a dual action of warming and cooling sensations upon application, aimed at alleviating pain and promoting comfort. The product is packaged in a convenient container, ensuring ease of use and storage.

Uses and Indications

This drug is indicated for use as directed. It is essential to avoid contact with the eyes or mucous membranes during application. The drug should not be bandaged tightly or used in conjunction with a heating pad. Additionally, it is contraindicated for application on wounds or damaged skin.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage involves applying a generous amount of the product to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, with a maximum frequency of four times daily.

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

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

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 swallowing, 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 a healthcare provider if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days. These signs may indicate a need for reevaluation of the treatment plan.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately to ensure appropriate management and care.

Side Effects

Patients should be aware of the potential for adverse reactions associated with the use of this product. Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use to mitigate the risk of allergic reactions.

This product is intended for external use only. Patients should discontinue use and seek medical advice if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, it is recommended that patients stop use and consult a doctor.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to using this medication. This precaution is essential to avoid potential allergic reactions, which may pose significant health risks. Monitoring for signs of an allergic response is advised in individuals with such sensitivities.

Packaging & NDC

Below are the non-prescription pack sizes of Duane Reade (methyl salicylate and menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended application involves generously applying the product to the affected area and massaging it into the skin until fully absorbed. This process may be repeated as necessary, but should not exceed four applications per day.

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

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 potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 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 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 data, 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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be informed to discontinue use and consult a doctor if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days. It is important for patients to be aware of these signs to ensure their safety and effective management of their condition.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.

To ensure optimal preservation, the container should be kept tightly closed when not in use. It is also important to note that the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years should apply the product generously to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of four times daily. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients regarding potential allergic reactions, particularly for those with known sensitivities to aspirin or salicylates. Pregnant or breastfeeding individuals should also seek professional advice before using the product. It is essential to keep the product out of reach of children, and in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Duane Reade, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)