Extra Strength Pain Relief Cream

Description

Sagely Naturals Extra Strength Pain Relief Cream is formulated to provide instant cooling relief. This topical preparation contains 10% menthol as an active ingredient, contributing to its analgesic properties. The cream is composed of 95% natural ingredients, ensuring a formulation that aligns with natural product standards. It is packaged in a 4 fluid ounce (118 mL) container, suitable for topical application.

Uses and Indications

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

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged, broken, or irritated skin is prohibited due to the potential for exacerbating the condition and causing further irritation. Additionally, concurrent use with a heating pad is contraindicated, as this may lead to increased risk of adverse effects.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to wounds or any areas of damaged, broken, or irritated skin. Additionally, the use of this product in conjunction with a heating pad is contraindicated.

While using this product, care should be taken to avoid contact with the eyes and mucous membranes. It is also advised that the area of application not be tightly bandaged, as this may lead to adverse effects.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for application on wounds or damaged, broken, or irritated skin, and should not be used in conjunction with a heating pad.

During use, patients are advised to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area of application. If the condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use. Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made without delay.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Pain Relief Cream (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 adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for 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 breastfeeding safety. 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 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 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 these contexts.

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. 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 on damaged, broken, or irritated skin. It is also important to counsel patients against using the product in conjunction with a heating pad.

Healthcare providers should recommend that patients 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 recur within a few days.

Additionally, patients should be cautioned to avoid contact with eyes or mucous membranes while using the product. They should also be advised not to bandage the area tightly when applying the product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. 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 Extra Strength Pain Relief Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)