Owell Naturals Pain Relief Cream

Description

Owell Pain Relief Cream is a topical formulation designed for the alleviation of pain. The cream is presented in a convenient dosage form, allowing for easy application to affected areas. Its composition includes a blend of active and inactive ingredients that work synergistically to provide targeted relief. The product is characterized by its smooth texture and is formulated to be absorbed quickly into the skin, enhancing its efficacy.

Uses and Indications

This drug is indicated for the relief of arthritis pain, sore joints and muscles, sore throat, sinus trouble, and restless leg syndrome.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

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 directly to the affected area. For children under 12 years of age, it is advised to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in situations where accidental ingestion by children may occur. To prevent potential harm, it is essential to keep the 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.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician if they have a known allergy to aspirin or salicylates prior to using this product.

This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. It is contraindicated for use in children under 12 years of age who present with arthritis-like conditions. Patients should be instructed to seek medical advice if there is any redness over the affected area before proceeding with use.

During application, it is crucial to avoid contact with the eyes and other sensitive areas. Additionally, patients should be cautioned against applying tight bandages over the treated area.

Patients must be advised to discontinue use and contact their healthcare provider if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops.

Emergency medical assistance should be sought immediately if the product is ingested. It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should contact a Poison Control Center or seek medical help without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. Individuals with a known allergy to aspirin or salicylates are advised to consult their healthcare provider prior to use. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Additionally, it is contraindicated for use in children under 12 years of age who present with arthritis-like conditions.

While using this product, patients should take care to avoid contact with the eyes or other sensitive areas and should refrain from tightly bandaging the area of application.

Patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

Furthermore, it is crucial to keep this product out of reach of children to prevent accidental ingestion. In the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult their healthcare provider prior to using this medication, as there is a potential risk of allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary. However, it is always advisable for patients to inform their healthcare provider of all medications and supplements they are currently taking to ensure comprehensive care.

Packaging & NDC

Below are the non-prescription pack sizes of Owell Naturals Pain Relief Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a doctor before use.

Geriatric Use

There is no specific information 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

The safety of Owell Naturals Pain Relief Cream during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals are advised to exercise caution when recommending this product to pregnant patients. There are no available studies or clinical data to assess potential risks or fetal outcomes associated with the use of this cream during pregnancy. Women of childbearing potential should be informed of the lack of safety information and encouraged to discuss any concerns with their healthcare provider before using this product.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

Accidental ingestion of the medication can pose significant health risks, particularly in children. It is imperative to keep the product out of reach of children to prevent such occurrences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay if the medication is swallowed. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

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 medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It is essential to store the product at room temperature to maintain its integrity and effectiveness. To ensure safety, the product should be kept out of reach of children to prevent accidental ingestion. Additionally, it is advised to discard the product after opening to avoid any potential risks associated with prolonged exposure to air or contaminants.

Additional Clinical Information

The route of administration for the medication is topical. Clinicians should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Owell Naturals Pain Relief Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)