Comforte Menstrual Cramp Relief Cream

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with cramps. It is intended for use in patients experiencing such discomfort.

Dosage and Administration

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

Healthcare professionals are advised to consult a physician before recommending this product for use in children aged 12 years or younger.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may lead to adverse effects. Additionally, contact with the eyes or mucous membranes should be strictly avoided to prevent irritation or injury. The product should not be applied to wounds or damaged skin, as this may compromise healing and increase the risk of complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to exercise caution, particularly those with a known allergy to aspirin or salicylates. Such individuals are encouraged to consult a physician prior to use to mitigate the risk of an allergic reaction.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops. These actions are crucial to ensure patient safety and effective management of their condition.

In the event of accidental ingestion, it is imperative to obtain emergency medical assistance immediately or contact a Poison Control Center. Prompt action is essential to address potential complications associated with ingestion.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only. Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use to avoid potential allergic reactions.

Patients are instructed to discontinue use and seek medical advice if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, medical consultation is recommended.

While using this product, it is crucial to adhere strictly to the directions provided. Patients should avoid tightly bandaging the area of application or using the product in conjunction with a heating pad. Care should be taken to prevent contact with the eyes or mucous membranes, and the product should not be applied to wounds or damaged skin.

In the event of accidental ingestion, patients should seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

Patients with a known hypersensitivity to aspirin or salicylates should seek medical advice prior to using this medication. This precaution is essential to prevent potential allergic reactions.

No specific interactions with other drugs or laboratory tests 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 Comforte Menstrual Cramp Relief Cream (menthol). 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. For adolescents and adults over 12 years, 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.

Geriatric Use

There is no specific information regarding the use of Comforte Menstrual Cramp Relief Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering the use of this product in elderly patients, as the absence of data necessitates careful monitoring and assessment of individual patient needs and responses.

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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 accidental ingestion, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is crucial to mitigate potential risks associated with overdosage.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure appropriate interventions can be implemented swiftly.

In all cases of suspected overdosage, the involvement of poison control experts can provide valuable guidance on specific management strategies tailored to the substance and the patient's needs.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of accidental ingestion of the product.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve but then reappear within a few days; or if excessive skin irritation develops.

When using this product, it is essential for patients to follow the directions provided. They should be cautioned against bandaging the area tightly or using the product in conjunction with a heating pad. Additionally, patients must be reminded to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin.

Storage and Handling

The product is supplied in a tube format. It should be stored at room temperature, away from direct light exposure. To maintain product integrity, the tube must be kept tightly closed when not in use. It is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children over 12 years, it should be applied generously to the affected area and massaged into the skin until fully absorbed. This application can be repeated as necessary, but should not exceed four times daily. Clinicians are advised to consult a doctor for guidance regarding use in children aged 12 years or younger.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Comforte Menstrual Cramp Relief Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)