Painbloc24 Prowomen Womens Discomforts Menthol Pain and Sleep Patch

Description

No specific information related to the Description section for SPL code 34089-3 is available in the provided text.

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, muscle strains, arthritis, bruises, and sprains.

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

Dosage and Administration

For adults over 18 years of age, the affected area should be cleaned and dried thoroughly prior to application. It is recommended to trim any excessive hair in the area to ensure optimal adhesion of the patch.

To apply the patch, the healthcare professional should instruct the patient to open the pouch and carefully remove the patch. The backing of the patch should be removed by grasping both ends and pulling the backing apart. The patient should then peel off one half of the backing and place the patch onto the affected area. After positioning the patch, the other half of the backing should be peeled off, and the patch should be pressed and smoothed onto the skin.

The patch may be used as needed for a duration of up to 8 hours. It is important to advise patients not to remove the patch when it is wet or immediately after showering or bathing. The patch should be allowed to dry before it is slowly removed. Only one patch should be used at a time, and the maximum duration of use should not exceed 8 hours.

For children under 18 years of age, it is essential to consult a doctor before use.

Contraindications

The product should not be used in the following situations:

Application should not involve tight bandaging, as this may compromise circulation. The use of heating pads in conjunction with the product is contraindicated due to the potential for increased skin irritation or burns. Additionally, the product must not be applied to wounds, damaged, broken, or irritated skin to prevent exacerbation of the condition. Concurrent use with other topical analgesics is also contraindicated to avoid potential interactions and increased risk of adverse effects.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals are advised to recommend that patients consult their physician prior to use if they are concurrently taking any medications or supplements that contain similar active ingredients.

It is imperative to avoid bandaging the area tightly and to refrain from using a heating pad in conjunction with this product. Contact with the eyes and mucous membranes must be avoided to prevent irritation. Additionally, the product should not be applied to wounds, damaged, broken, or irritated skin. The simultaneous use of other topical analgesics is contraindicated.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens; redness persists, spreads, or becomes tender; symptoms last longer than 7 days or resolve only to recur within a few days; or if burning, swelling, or blistering develops at the application site.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product may experience a range of adverse reactions. It is important to note that this product is for external use only and should be used strictly as directed. Patients are advised to consult their healthcare provider prior to use if they are taking any medications or supplements that contain similar ingredients.

Serious adverse reactions may include burning, swelling, or blistering at the site of application. Patients should discontinue use and seek medical advice if any of these symptoms occur. Additionally, if the condition worsens, if redness persists, spreads, or becomes tender, or if symptoms last more than 7 days or recur shortly after resolution, patients should also stop use and consult a doctor.

Common adverse reactions may involve irritation at the application site. Patients should avoid contact with eyes and mucous membranes, and the product should not be applied to wounds, damaged, broken, or irritated skin. It is also advised not to use the product in conjunction with other topical analgesics, not to bandage tightly, and not to use it with a heating pad.

For pregnant or breastfeeding patients, it is recommended to seek advice from a healthcare professional before using this product. Furthermore, the product should be kept out of reach of children, and in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

Concurrent use of medications or supplements containing the same active ingredients should be approached with caution. It is advisable for patients to consult their healthcare provider prior to initiating treatment to avoid potential additive effects or toxicity.

Topical analgesics should not be used simultaneously with this product. The co-administration of multiple topical analgesics may increase the risk of adverse effects and should be avoided to ensure patient safety and efficacy of treatment.

Packaging & NDC

Below are the non-prescription pack sizes of Painbloc24 Prowomen Womens Discomforts Menthol Pain and Sleep Patch (menthol 6%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 18 years of age should consult a healthcare professional prior to use. It is essential to evaluate the appropriateness of treatment and dosage for this population, as specific recommendations may vary based on individual clinical circumstances.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare 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 mothers.

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 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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a healthcare professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 any of the following occur: the condition worsens, redness persists, spreads, or becomes tender, symptoms last more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, they should seek medical advice if they experience burning, swelling, or blistering at the application site.

When using this product, patients must be instructed to use it only as directed. They should consult their doctor before use if they are taking any medications or supplements that contain the same active ingredients. It is important to advise patients not to bandage the area tightly or use a heating pad in conjunction with the product. They should also be cautioned to avoid contact with eyes and mucous membranes, and not to apply the product to wounds, damaged, broken, or irritated skin. Furthermore, patients should be informed not to use this product simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in a configuration that allows for the use of one patch at a time for a duration of up to 8 hours. It is essential to store the patches in a cool, dry place at room temperature to maintain their efficacy.

Care should be taken when handling the patches; they should not be removed when wet or immediately after showering or bathing. It is recommended to allow the patch to dry before slowly removing it. Once opened, the patches must be discarded appropriately to ensure safety and compliance with handling guidelines.

Additional Clinical Information

The route of administration for the product is topical, with the patch to be used as needed for a maximum duration of 8 hours. Clinicians should advise patients not to remove the patch when wet or immediately after showering or bathing; instead, the patch should be allowed to dry before being slowly removed. Only one patch should be used at a time within the 8-hour period.

Patients who are pregnant or breastfeeding should consult a healthcare professional prior to use. It is also important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Painbloc24 Prowomen Womens Discomforts Menthol Pain and Sleep Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)