Cvs Pain Relief

Description

The product is a colorless gel formulation containing 85 grams of the active ingredient. Inactive ingredients include carbomer, triethanolamine, propylene glycol, purified water, methylparaben, propylparaben, and sodium hydroxide. The SPL Code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. Specifically, it is effective for conditions such as arthritis, backache, strains, and sprains.

Limitations of Use: 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 once daily. 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 to ensure safety and appropriateness of treatment.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Concurrent use with other ointments, creams, sprays, or liniments is not recommended, as this may lead to unpredictable interactions. The product should not be applied to irritated skin or in cases where excessive irritation develops, as this could exacerbate the condition. Additionally, bandaging or the use of heating pads or devices in conjunction with the product is contraindicated, as this may increase the risk of adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. It is imperative that the product is used only as directed. Patients should be cautioned to avoid contact with the eyes or mucous membranes and to refrain from applying the product to wounds or damaged skin. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended. Additionally, it should not be applied to irritated skin or if excessive irritation develops. Bandaging or the use of heating pads or devices in conjunction with this product is contraindicated.

Storage should be in a cool, dry place, away from direct sunlight. Patients are advised to wash their hands with cool water after application to prevent unintended contact with other areas of the body.

In the event of accidental ingestion, immediate medical assistance should be sought, or poison control should be contacted at 1-800-222-1222.

Patients should be 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.

Side Effects

Patients should be aware of several important warnings associated with this product. It is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

Before using this product, patients with sensitive skin should consult a doctor. 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 are advised to stop use and seek medical advice.

During the use of this product, patients should avoid contact with the eyes or mucous membranes and should not apply it to wounds or damaged skin. It is also important not to use this product in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying it to irritated skin or if excessive irritation develops. Additionally, the product should not be bandaged or used with a heating pad or device.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before use. This product should be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or contact a poison control center at 1-800-222-1222.

Drug Interactions

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical products may lead to altered absorption, increased risk of local irritation, or diminished therapeutic efficacy. It is advised to avoid concurrent use to ensure optimal treatment outcomes and minimize potential adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Pain Relief (menthol 4%). 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 once daily, without the need for massage. For children under 2 years of age, it is advised to consult a physician prior to use.

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

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 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 absence of guidance 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 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, it is crucial to keep the product out of reach of children. Accidental ingestion may occur, and immediate medical assistance should be sought. Healthcare professionals are advised to contact a poison control center without delay; in the United States, the National Capital Poison Center can be reached at 1-800-222-1222.

Prompt recognition of symptoms associated with overdosage is essential for effective management. While specific symptoms are not detailed in the provided information, healthcare providers should remain vigilant for any unusual or severe reactions following ingestion.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is recommended, and further interventions may be warranted based on the clinical presentation.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact Poison Control at 1-800-222-1222 if the medication is accidentally ingested. It is important to instruct patients to use the medication only as directed and to avoid contact with the eyes or mucous membranes.

Patients should be informed not to apply the medication to wounds or damaged skin and to refrain from using it in conjunction with other ointments, creams, sprays, or liniments. They should also be cautioned against applying the medication to irritated skin or if excessive irritation develops.

Additionally, healthcare providers should emphasize that the medication should not be bandaged or used with heating pads or devices. Patients should be advised to store the medication in a cool, dry place away from direct sunlight and to wash their hands with cool water after use to prevent unintended exposure.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored in a cool, dry place, away from direct sunlight to maintain its integrity. Care must be taken to keep the product away from excessive heat and open flames, as it is flammable.

Additionally, it is recommended that healthcare professionals wash their hands with cool water after handling the product to ensure proper hygiene.

Additional Clinical Information

Patients aged 2 years and older are advised to apply a thin film of the product over the affected areas no more than once daily, without the need for massage. For children under 2 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact a poison control center at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)