Painbloc24 Prowomen Pain Relief Patch

Description

This product is presented in a packaging format that includes visual representations for identification. The effective date of this packaging is July 5, 2021. Two images are provided to illustrate the packaging design: the first image is referenced as "7122600321.jpg" and the second as "7122600321-2.jpg." These images serve to enhance the understanding of the product's appearance and labeling.

Uses and Indications

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

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

Dosage and Administration

Adults and children over 12 years of age should begin by cleaning and drying the affected area thoroughly. It is advisable 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; instead, they should allow the patch to dry before slowly removing it. The patch should be applied to the affected area no more than 3 to 4 times daily.

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

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid bandaging the area tightly and to refrain from using it in conjunction with a heating pad. Contact with the eyes and mucous membranes should be avoided, and the product must not be applied to wounds, damaged, broken, or irritated skin. Additionally, concurrent use with other topical analgesics is contraindicated.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, development of redness or irritation, persistence of symptoms beyond 7 days, recurrence of symptoms after initial resolution within a few days, or the experience of burning, swelling, or blistering at the application site.

In cases where the patient is pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use.

Emergency medical assistance should be sought immediately if the product is ingested, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only. When using this product, it is essential to adhere strictly to the directions provided. Patients are advised not to bandage the area tightly, use it in conjunction with a heating pad, or apply it to wounds, damaged, broken, or irritated skin. Additionally, contact with the eyes and mucous membranes should be avoided, and the product should not be used simultaneously with other topical analgesics.

In the event that the condition worsens, or if redness or irritation develops, patients should discontinue use and consult a healthcare professional. Symptoms that persist for more than 7 days, or that clear up and then recur within a few days, warrant a similar course of action. Patients should also seek medical advice if they experience burning, swelling, or blistering at the site of application.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use to ensure safety.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advisable to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimize treatment efficacy. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern about overlapping therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Painbloc24 Prowomen Pain Relief Patch (natural menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age 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

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. 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 healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 compound in these areas.

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. It is crucial to inform patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is essential to ensure patient safety and prompt action in case of an emergency.

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, maintaining a room temperature environment to ensure its stability and efficacy. Proper handling should be observed to prevent exposure to extreme temperatures or humidity, which could compromise the product's integrity.

Additional Clinical Information

The product is administered topically, with the patch being used as needed for a duration of up to 8 hours. Clinicians should advise patients not to remove the patch when it is wet or immediately after showering or bathing; instead, the patch should be allowed to dry before being slowly removed. It is recommended that the patch be applied to the affected area no more than 3 to 4 times daily.

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 Painbloc24 Prowomen Pain Relief Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)