Proinnate Numbing Cream

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

The medication should be applied to the affected area no more than three times daily. It is important to ensure that the application is performed gently and that the area is clean and dry prior to use. Healthcare professionals should advise patients to follow the prescribed frequency and to avoid exceeding the recommended dosage to minimize the risk of adverse effects.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients. Additionally, the product should not be used if the seal is broken or missing, as this may indicate contamination or compromised integrity.

This product is also contraindicated in children under 2 years of age due to safety concerns.

Warnings and Precautions

For external use only. This product is contraindicated in children under 2 years of age. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients not to use this product if they have a known allergy to any of its ingredients. Additionally, the product should not be used if the seal is broken or missing, as this may indicate contamination or compromised integrity.

Patients should be instructed to discontinue use and consult a physician if a rash develops during treatment. Monitoring for any adverse reactions is essential to ensure patient safety.

Side Effects

Patients should be aware that the product is intended for external use only. In clinical practice, if a rash occurs, it is advised to stop use and consult a healthcare professional. This precaution is essential to ensure patient safety and to address any potential adverse reactions that may arise during treatment.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Proinnate Numbing Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. The use of this medication is not recommended in children under 2 years of age.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. 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

There is no information available regarding the use of Proinnate Numbing Cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider this lack of data when prescribing this medication to pregnant patients. The potential risks to fetal outcomes remain undetermined due to the absence of clinical or animal studies addressing the effects of this drug in pregnant individuals. Therefore, women of childbearing potential should be advised to discuss their pregnancy status and any potential risks with their healthcare provider before using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage in the available sections of the drug insert, healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage cases.

Healthcare providers should monitor patients closely for any potential symptoms that may arise from an overdose. Although no specific symptoms are detailed, it is prudent to remain vigilant for any unusual clinical presentations that may suggest an adverse reaction to excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare professionals initiate supportive care as necessary. This may include symptomatic treatment and monitoring of vital signs. Additionally, consultation with a poison control center or a medical toxicologist may be beneficial to guide further management and intervention strategies.

Overall, due to the lack of detailed overdosage information, a conservative approach should be taken, prioritizing patient safety and the implementation of standard emergency protocols.

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 this product out of reach of children to prevent accidental ingestion. It is important to inform patients that the product should not be used in children under 2 years of age. In the event of accidental swallowing, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against using the product if they have a known allergy to any of its ingredients or if the product's seal is broken or missing, as this may indicate compromised safety. Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if a rash occurs during use.

When using this product, patients should be reminded to avoid contact with the eyes. If the product does come into contact with the eyes, they should rinse thoroughly with water to remove it.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its efficacy. Healthcare professionals are advised to discard any unused product after opening to ensure safety and quality.

Additional Clinical Information

The medication is administered topically, with application to the affected area not exceeding three times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Proinnate Numbing Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)