Stopain Extra Strength Gel

Description

No relevant information is available for SPL code 34089-3.

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

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may exacerbate adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent potential complications and ensure safety.

Warnings and Precautions

For external use only; direct contact with the eyes must be avoided to prevent irritation. The product is flammable; therefore, it should be kept away from fire or flame to mitigate the risk of combustion.

It is imperative to use this product only as directed. Users should refrain from tightly bandaging the area of application or using a heating pad, as these practices may exacerbate adverse effects. Additionally, the product should not be applied to wounds or damaged skin to ensure safety and efficacy.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. The presence of redness or excessive skin irritation also warrants immediate medical consultation.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance 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 irritation of the skin develops.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 aged 2 years and older may apply the medication directly onto the affected area, with a recommended frequency of 3 to 4 times daily. It is advised that hands be washed after application to prevent unintentional exposure.

For children under 2 years of age, the use of this medication is not recommended without prior consultation with a healthcare professional.

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 prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population.

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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. 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 administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 to instruct patients to 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 be made aware of the potential for redness and excessive irritation of the skin. They should be counseled to use the product only as directed and to avoid tightly bandaging the area or using a heating pad in conjunction with the treatment. Additionally, patients must be informed not to apply the product to wounds or damaged skin to prevent further complications.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. It is imperative to keep the product out of reach of children to prevent accidental ingestion or misuse.

Due to its flammable nature, the product must be kept away from fire or flame to ensure safety during storage and handling. Additionally, it is recommended that hands be washed thoroughly after use to maintain hygiene and prevent any potential contamination.

Additional Clinical Information

The medication is administered topically, with specific guidelines for different age groups. Adults and children aged 2 years and older should apply the product directly to the affected area no more than 3 to 4 times daily, ensuring to wash hands after use. For children under 2 years of age, the product should not be used without consulting a doctor.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)