Feminine Pain Relief

Description

unexo® is a medicated feminine pain relief patch designed to alleviate menstrual discomfort. Each pack contains five patches, which are formulated for fast-acting relief from period cramps. The patches are intended for application for a duration of 8 to 12 hours, providing targeted support during menstruation. The product is identified by the National Drug Code (NDC) 71391-130-05 and is developed by LIFE SCIENCES.

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, it is essential to 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 affix the sticky side directly to the affected area. In cases where the patch is applied to hairy skin, it should be removed gently using mild warm water to minimize discomfort.

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

Contraindications

Use is contraindicated in the following situations:

Application on open wounds, cuts, eyes, and face is prohibited due to the risk of irritation and potential complications. Additionally, the use of a heating pad in conjunction with this product is contraindicated, as it may lead to increased absorption and adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation. Furthermore, tight bandaging is not recommended, as it may restrict circulation and lead to further complications.

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. It is also advised not to apply a tight bandage over the treated area.

Healthcare professionals should instruct 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 application.

This product should be kept 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 using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only and should not be applied to open wounds, cuts, the eyes, or the face. Additionally, it should not be used in conjunction with a heating pad.

During use, patients are advised to avoid contact with the eyes and mucous membranes and to refrain from tightly bandaging the treated area. It is recommended that patients consult their healthcare provider prior to use if they experience redness over the affected area, have sensitive skin, or are pregnant or breastfeeding.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if abnormal skin irritation occurs after usage, medical consultation is advised.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

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 this population, aligning with adult use. There is currently no data available for children under 12 years of age.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, may use this medication; however, there are no specific geriatric use information or dosage adjustments indicated in the prescribing information. Additionally, no safety concerns or special precautions for elderly patients have been provided.

Healthcare providers should continue to monitor the overall health status of geriatric patients when prescribing this medication, as individual responses may vary.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

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 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 intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on open wounds, cuts, or on the eyes and face. Additionally, they should be cautioned against using the product in conjunction with a heating pad, as this may lead to adverse effects.

It is important for healthcare providers to instruct patients to stop using the product 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 discontinue use and seek medical advice if they experience any abnormal skin irritation following application.

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

Healthcare providers should encourage patients to consult with their doctor before using the product if they have redness over the affected area, have sensitive skin, or are pregnant or breastfeeding. This ensures that patients receive appropriate guidance tailored to their individual health needs.

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 consult their doctor prior to use if they experience redness over the affected area, have sensitive skin, or are pregnant or breastfeeding. Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than seven days, or if abnormal skin irritation occurs after 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)