Nitroval Blue

Description

NitroValBLUE is a topical analgesic cream formulated for pain relief. It is manufactured by Plum Valley Pharma, LLC, located in Dearborn, MI, USA. The product is available in a net weight of 3 oz. (85 g) and is intended for topical use only. The National Drug Code (NDC) for this product is 82226-160-85. For inquiries or additional information, a toll-free number is provided: 866-248-1553.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, simple backache, strains, bruises, and sprains.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application involves massaging the product onto the affected areas. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period. It is advised to wash hands thoroughly with cool water after each use to prevent unintentional contact with sensitive areas.

For children under 12 years of age, it is essential to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

The product is contraindicated in the following situations:

• Co-administration with other ointments, creams, sprays, or liniments is not recommended due to potential interactions that may affect efficacy or safety.

• Application to irritated skin or in cases where excessive irritation develops is contraindicated to prevent exacerbation of the condition.

• Bandaging the area or using heating pads or devices in conjunction with the product is not advised, as this may lead to increased absorption and potential adverse effects.

• Contact with the eyes or mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin to minimize the risk of irritation or adverse reactions.

Warnings and Precautions

For external use only. It is imperative to keep the product away from excessive heat or flame. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use. The product must be kept out of reach of children; in the event of accidental ingestion, immediate medical assistance should be sought or the Poison Control Center contacted.

Healthcare professionals should advise patients to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then return.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact the Poison Control Center without delay.

General precautions include avoiding contact with the eyes and mucous membranes, and refraining from applying the product to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments. It is also advised not to apply the product to irritated skin or if excessive irritation develops. Bandaging the area or using a heating pad or device in conjunction with the product is not recommended. After application, hands should be washed thoroughly with cool water.

No specific laboratory tests are required for the safe use of this product.

Side Effects

Patients should be aware that the product is for external use only and should be kept away from excessive heat or flame to prevent potential hazards.

In the event of adverse reactions, patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then return. These precautions are essential to ensure the safety and well-being of individuals using the product.

Drug Interactions

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical products may lead to altered absorption, increased risk of local irritation, or diminished therapeutic efficacy. It is advised to avoid concurrent use to ensure optimal treatment outcomes and minimize potential adverse effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended application involves massaging the product onto the affected areas. This can be repeated as needed, but should not exceed four times daily. It is advised to wash hands with cool water after application to prevent unintended exposure.

Geriatric Use

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

Due to the absence of clinical findings or data specific to this population, it is advisable for healthcare providers to closely monitor elderly patients for any adverse effects or unusual responses to treatment. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing therapy for this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to 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 seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health 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

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of these aspects remains incomplete.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to consult a health professional before using this product if they are pregnant or breastfeeding. It is important to instruct patients to keep the product out of reach of children and to seek medical help or contact the Poison Control Center immediately if the product is accidentally ingested.

Patients should be informed to store the product in a cool, dry place and to ensure that the cap is closed tightly after each use. They should be cautioned to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then return.

When using this product, patients should be advised to avoid contact with the eyes and mucous membranes, and not to apply it to wounds or damaged skin. They should not use the product in conjunction with other ointments, creams, sprays, or liniments. Additionally, patients should be instructed not to apply the product to irritated skin or if excessive irritation develops. It is also important to inform patients not to bandage the area after application and to avoid using heating pads or devices in conjunction with the product. Finally, patients should be reminded to wash their hands with cool water after use.

Storage and Handling

The product is supplied in a secure container that must be stored in a cool, dry place to maintain its integrity. It is essential to ensure that the cap is closed tightly after each use to prevent contamination and preserve the product's efficacy.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children aged 12 years and older should apply and massage the product onto the affected areas, with a maximum frequency of four times daily. For children under 12 years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only and should be kept away from excessive heat or flame. Patients must avoid contact with the eyes and mucous membranes, and should not apply it to wounds or damaged skin. It is important not to use the product in conjunction with other ointments, creams, sprays, or liniments, and to refrain from applying it to irritated skin or if excessive irritation occurs. Bandaging the area or using heating pads/devices is not recommended. Patients should wash their hands with cool water after application and discontinue use if the condition worsens, symptoms persist beyond seven days, or if symptoms clear and then return. Pregnant or breastfeeding individuals should consult a healthcare professional before use. The product should be kept out of reach of children, and in case of accidental ingestion, medical help or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)