Amp Relief Pain Relief Cream

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

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

Limitations of Use: This drug is intended for short-term use and should not be used as a substitute for more comprehensive treatment of underlying conditions.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated in patients with damaged or broken skin due to the potential for exacerbating the condition and hindering proper healing.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to damaged or broken skin to prevent adverse reactions.

When utilizing this product, care should be taken to avoid contact with the eyes. Additionally, it is advised not to apply a tight bandage over the area of application, as this may lead to increased irritation or other complications.

Users should discontinue use and consult a healthcare professional if any of the following occur: a rash or irritation develops and persists; the condition worsens; symptoms do not improve after 7 days; or if the condition appears to resolve only to recur within a few days.

To ensure safety, this product must 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 is recommended.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be applied to damaged or broken skin. During use, it is important to avoid contact with the eyes and to refrain from tightly bandaging the area of application.

In the event that a rash or irritation develops and persists, or if the condition worsens, patients are advised to discontinue use and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days, or if the condition appears to clear up only to recur within a few days, medical advice should be sought.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be obtained or a Poison Control Center contacted.

Pregnant or breastfeeding individuals are encouraged to consult a healthcare professional prior to using this product to ensure safety.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 weighed, 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 mothers.

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 and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product to damaged or broken skin to prevent further complications.

Patients should be informed to discontinue use and consult a doctor if they experience any rash or irritation that develops and persists. Additionally, they should be advised to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than 7 days. If the symptoms initially improve but then recur within a few days, patients should also be encouraged to consult a healthcare professional.

While using the product, patients must be cautioned to avoid contact with the eyes to prevent irritation or injury. Furthermore, they should be instructed not to bandage the area tightly when using the product, as this may lead to adverse effects.

Storage and Handling

The product is supplied in configurations that are compliant with the relevant NDC numbers. It is essential to store the product in a cool, dry place, away from excessive heat or open flame, due to its flammable nature. Proper handling procedures should be followed to ensure safety and maintain product integrity.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is recommended prior to use. Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding before using the product. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)