Relief Gel

Description

Good Clean Love is a relief gel formulated to alleviate pain and itching associated with external vaginal discomfort. This product contains 4% lidocaine, a local anesthetic that provides targeted relief from irritation. It is gynecologist recommended and is available in a dosage form of 1 fluid ounce (29 mL).

Uses and Indications

This drug is indicated for the temporary relief of vaginal pain, itch, and irritation. It provides symptomatic relief from irritation and external vaginal discomfort.

Dosage and Administration

Healthcare professionals are advised to follow the outlined procedures for the application of the gel. Prior to application, the affected area should be cleaned thoroughly and gently dried to ensure optimal effectiveness.

The gel should be applied to the vulva, labia, and vaginal opening as needed to alleviate symptoms of itching, burning irritation, and to soothe irritated skin. It is important to limit the application to no more than 3 to 4 times daily unless otherwise directed by a physician.

After each use, the nozzle must be cleaned to maintain hygiene and prevent contamination. Ensure that the nozzle is closed tightly after cleaning to preserve the integrity of the product.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion or misuse.

• Discontinue use and consult a healthcare professional if an allergic reaction occurs.

• If the condition worsens or does not improve, seek medical advice.

• Stop use if redness, irritation, or swelling develops.

Warnings and Precautions

For external use only; contact with eyes should be strictly avoided. This product should not be applied to large areas of skin to prevent potential adverse effects.

Healthcare professionals are advised to counsel patients to consult a physician prior to use if they are pregnant, attempting to conceive, or currently breastfeeding. This precaution is essential to ensure the safety of both the patient and the fetus or infant.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: an allergic reaction, worsening of the condition, or the appearance of redness, irritation, or swelling. These symptoms may indicate a need for further evaluation and management.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay to receive appropriate guidance and intervention.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious reactions include allergic reactions, which necessitate immediate discontinuation of use and consultation with a healthcare provider. Additionally, if the condition being treated worsens or does not improve, patients are advised to seek medical advice.

Common adverse reactions may include redness, irritation, or swelling at the site of application. In such cases, patients should also stop use and consult a doctor.

It is important to note that this product is for external use only. Patients should avoid contact with the eyes and refrain from applying it to large areas of skin to minimize the risk of adverse effects.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Relief Gel (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Geriatric Use

There is no specific information available 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, those trying to conceive, or breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 available 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 without delay. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to discontinue use and consult their healthcare provider if they experience any signs of an allergic reaction, if their condition worsens or does not improve, or if they notice any redness, irritation, or swelling.

Additionally, it is important for healthcare providers to recommend that patients consult with their doctor before using the medication if they are pregnant, trying to conceive, or breastfeeding. This ensures that any potential risks are adequately assessed and managed.

Storage and Handling

The product is supplied with a tamper-resistant seal to ensure safety and integrity. It is imperative that the product not be used if the seal is found to be broken or not intact.

For optimal storage conditions, the product should be maintained at room temperature, specifically within the range of 68°F to 77°F. Proper adherence to these storage guidelines is essential to preserve the product's efficacy and safety.

Additional Clinical Information

The medication is administered topically, with the gel applied to the vulva, labia, and vaginal opening as needed to alleviate symptoms such as itching and burning irritation, as well as to soothe irritated skin. Clinicians should advise patients not to exceed the application of the gel more than 3-4 times daily unless otherwise directed by a healthcare professional.

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 Relief Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)