Feminine Pain Relief

Description

The product is a feminine pain relief patch manufactured by Unexo Life Sciences, identified by the National Drug Code (NDC) 71391-131-04. Each patch has a surface area of 50 cm² and contains menthol as an active ingredient. Designed to soothe period cramps, the patch is characterized by its fast-acting properties. It is intended for application for a duration of 8 to 12 hours and is supplied in a package containing four patches.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in the lower back and abdomen associated with cramps.

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

Dosage and Administration

For adults and children aged 12 years and older, the patch should be applied to the affected area no more than twice daily. Prior to application, ensure that the skin in the application area is completely dry.

To apply the patch, open the pouch and remove the patch. Peel off the protective film and apply the sticky side directly to the affected area. In cases where the patch is applied to hairy skin, it is recommended to remove the patch gently using mild warm water.

Once the patch has been used, it cannot be re-pasted or reused. Dispose of the patch properly after use to ensure safety and hygiene.

Contraindications

Use of this product is contraindicated in the following situations:

Application on open wounds, cuts, eyes, and face is prohibited due to the potential for irritation and adverse reactions. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to increased absorption and potential toxicity.

Warnings and Precautions

For external use only; this product must not be used in any manner other than as directed. It is imperative to avoid application on open wounds, cuts, the eyes, and the face. Additionally, the use of this product in conjunction with a heating pad is contraindicated.

When utilizing this product, care should be taken to prevent contact with the eyes and mucous membranes. Bandaging should not be applied tightly to the area of application.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should also seek medical advice if they experience any abnormal skin irritation following use.

It is essential 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 should be made without delay.

Side Effects

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients are advised to seek medical advice if they experience abnormal skin irritation following usage.

Before using the product, patients should inform their healthcare provider if they have redness over the affected area, have sensitive skin, or are pregnant or breastfeeding.

This product is intended for external use only and should not be used in any manner other than as directed.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Feminine Pain Relief (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may use this medication. There are no specific dosage adjustments or safety concerns noted for this age group. Efficacy and safety have been established for adolescents within this age range, aligning with the indications for adult use. Further studies may be warranted to evaluate outcomes in younger pediatric populations.

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, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult their healthcare provider before using this medication. The potential risks and benefits must be carefully considered in these populations. There is limited data available regarding the effects of this medication on fetal outcomes or during lactation, and therefore, healthcare professionals are advised to exercise caution and provide appropriate counseling to women of childbearing potential.

Lactation

Lactating mothers are advised to consult their healthcare provider prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should consider the potential risks and benefits when recommending this medication to lactating mothers.

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 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 intervention is crucial. If the substance is ingested, healthcare professionals are advised to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on open wounds, cuts, the eyes, or the face. Additionally, it is important to inform patients that the product should not be used in conjunction with a heating pad.

Healthcare providers should counsel patients to discontinue use and consult their 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. Patients should also be advised to stop using the product and seek medical advice if they experience any abnormal skin irritation after application.

While using the product, patients should be cautioned to avoid contact with the eyes and mucous membranes. They should also be informed not to bandage the area tightly after application.

Before using the product, patients should be encouraged to consult their doctor if they have redness over the affected area, have sensitive skin, or are pregnant or breastfeeding.

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, ensuring that the temperature does not exceed 80°F (27°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application to the affected area no more than twice daily. Clinicians should counsel patients to avoid contact with eyes and mucous membranes and to refrain from applying tight bandages over the treated area.

Patients are advised to consult their doctor prior to use if they experience redness over the affected area, have sensitive skin, or are pregnant or breastfeeding. They should discontinue use and seek medical advice if the condition worsens, symptoms persist beyond seven days, or if abnormal skin irritation occurs following application.

Drug Information (PDF)

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

View product document (PDF)