Stopain Extra Strength Gel

Description

The product is identified by SPL code 34089-3 and is formulated as a sterile, non-pyrogenic, isotonic solution. It contains sodium chloride, sodium bicarbonate, and dextrose, with the pH adjusted to a range of 7.0 to 7.5. The solution is packaged in a 946 mL container, and the inactive ingredient is water for injection.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to apply the product directly onto the affected area. This should not exceed 3 to 4 times daily. It is important to wash hands thoroughly after each use to prevent unintentional contact with other areas of the body or surfaces.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is advised not to bandage tightly or use a heating pad in conjunction with the product, as this may lead to increased risk of skin irritation or other complications.

Warnings and Precautions

For external use only, this product must be handled with care to ensure safety and efficacy. Healthcare professionals should advise patients to avoid contact with the eyes, as this may lead to irritation or injury. Additionally, the product is flammable; therefore, it should be kept away from fire or flame to prevent any hazardous situations.

When recommending this product, it is crucial to emphasize the importance of using it only as directed. Patients should be cautioned against tightly bandaging the area of application or using a heating pad, as these practices may exacerbate potential side effects. Furthermore, the product should not be applied to wounds or damaged skin to avoid complications.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. The presence of redness or excessive skin irritation also warrants immediate medical attention.

In the event of accidental ingestion, it is imperative to seek emergency medical help or contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only, and contact with the eyes should be avoided. It is also flammable; therefore, it should be kept away from fire or flame.

When using this product, it is crucial to adhere strictly to the directions provided. Patients should not bandage the area tightly or use a heating pad in conjunction with the product. Additionally, it should not be applied to wounds or damaged skin.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness is present, or excessive skin irritation develops.

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 in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information regarding the use of Stopain Extra Strength Gel in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or unique responses in this population. It is advisable to consider the overall health status and any comorbidities of geriatric patients when recommending this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to understand that they should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Patients should also be informed to stop using the product and consult a healthcare professional if they notice any redness or if excessive skin irritation develops. Emphasizing the importance of using the product only as directed is crucial for patient safety.

Additionally, healthcare providers should instruct patients not to bandage the area tightly or use a heating pad while using this product. It is also essential to advise patients against applying the product to wounds or damaged skin to prevent complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

For patients aged 12 years and older, the medication should be applied directly to the affected area without the need for bandaging, with a maximum frequency of four applications per day. For children under 12 years, it is advised to consult a doctor prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Stopain Extra Strength Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)