Pain Relieving

Description

The Pain Relieving Gel, manufactured by Safetec of America, Inc., is designed for the relief of minor aches and pains associated with muscles and joints. This product is presented in a 4 oz (113.4 g) container, with a reorder number of 58002. The gel is produced in India and is intended for professional use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, 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, a thin film of the medication should be applied to the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. It should not be applied to irritated skin or if excessive irritation develops, to prevent exacerbation of the condition. Bandaging the area after application is contraindicated, as it may alter the product's effectiveness. Additionally, the use of heating pads or devices in conjunction with this product is not advised, as it may increase the risk of irritation or other adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should be kept away from excessive heat or open flame to prevent any fire hazards.

Healthcare professionals are advised to inquire about the patient's skin sensitivity prior to recommending this product. Individuals with sensitive skin should consult a physician before use to avoid potential adverse reactions.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately. Patients should be instructed to contact a physician or the Poison Control Center without delay.

Patients should be advised to discontinue use and consult their healthcare provider if their condition worsens, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought promptly.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame. Patients with sensitive skin are advised to consult a doctor before use.

During application, it is crucial to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, bandaging the area after application is not recommended, and hands should be washed with cool water following use. The product should not be used with heating pads or devices.

Patients are instructed to discontinue use 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.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this medication is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not necessary in the context of drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the medication over affected areas up to four times daily, without the need for massage. For children under 2 years of age, consultation with a physician is advised prior to use.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately by contacting a physician or the Poison Control Center.

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. The potential risks and benefits must be carefully considered in these populations, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 medication 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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.

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 immediately by contacting a physician or the Poison Control Center.

Patients should be informed to 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.

When using this product, patients should be cautioned to avoid contact with the eyes and mucous membranes. They should not apply the product to wounds or damaged skin, nor should they use it in conjunction with other ointments, creams, sprays, or liniments. Patients should also be advised against applying the product to irritated skin or if excessive irritation develops. It is important to inform patients not to bandage the area after application and to wash their hands with cool water after use. Additionally, patients should be warned not to use the product with a heating pad or any heating device.

Finally, healthcare providers should recommend that patients consult a doctor before using the product if they have sensitive skin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains within its specified temperature range and is protected from moisture.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)