Osmoflex

Description

OsmoFlex™ is a pain-relieving cream formulated with menthol at a concentration of 1.3%. It is available in multiple net weights: 4 oz (113.4 g), 16 oz (453.6 g), and 32 oz (964.3 g). The product is distributed by Seablue Vitamins, LLC, located at 211 North Locksley Drive, Lafayette, LA 70508. For additional information, visit www.seabluevitamins.com.

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 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician prior to use.

When applying the product, a generous amount should be massaged into the affected area until fully absorbed. This technique ensures optimal delivery and effectiveness of the treatment.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation and delayed healing. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to excessive heat and increase the risk of adverse effects.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid contact with the eyes or mucous membranes to prevent irritation or injury. Additionally, patients should be instructed not to bandage the area tightly, as this may lead to adverse effects. The product should be used strictly as directed to ensure safety and efficacy.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, or excessive skin irritation. Furthermore, it is essential for pregnant or breastfeeding individuals to seek medical advice prior to using this product to ensure safety for both the mother and child.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if conditions worsen, if symptoms persist for more than 7 days, if symptoms clear up and then occur again within a few days, or if excessive skin irritation develops.

Additionally, it is advised that individuals who are pregnant or breastfeeding consult a doctor prior to use to ensure safety and appropriateness of the treatment.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Osmoflex (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a doctor 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, healthcare professionals should carefully consider the potential risks and benefits when recommending this medication to lactating patients.

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 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare professionals are advised to remain vigilant and prepared to manage any symptoms that may arise as a result of an overdose.

The management of overdosage should be guided by the specific clinical scenario and the patient's condition. Continuous monitoring and supportive care may be necessary to ensure patient safety and recovery.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to counsel patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to discontinue use and seek medical advice if symptoms resolve but then recur within a few days, or if they experience excessive skin irritation.

For patients who are pregnant or breastfeeding, it is essential to recommend consulting a doctor before using the product. While using this product, patients should be cautioned to avoid contact with eyes or mucous membranes. They should also be instructed not to bandage the area tightly and to use the product only as directed.

Storage and Handling

The product is supplied in a tamper-resistant container. It is essential to inspect the seal under the cap before use; do not use the product if the seal is broken or missing.

For optimal storage, the product should be kept at room temperature, specifically within the range of 20° to 25° C (68° to 77° F). Proper adherence to these storage conditions will help maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)