Acuplus Pain Relief

Description

AcuPlus Pain Relief Cream is presented in a 1-gallon container. The product is designed for topical application and is intended for pain relief. The effective date of the formulation is January 22, 2018. The media type associated with the product is image/jpeg, and the reference for the labeling is identified as Label 1Galon.jpg.

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, simple backache, strains, bruises, and sprains.

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

Dosage and Administration

The medication should be applied to the affected area no more than three to four times daily. For adults and children aged 2 years and older, it is recommended to consult a physician prior to use. For children under 2 years of age, consultation with a physician is also advised.

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, as this may exacerbate the condition. Bandaging the area after application is contraindicated to prevent occlusion. 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

Use of this product should be strictly in accordance with the provided directions. It is imperative to keep the product out of reach of children to prevent accidental ingestion or misuse. This formulation is intended for external use only; therefore, it must be kept away from excessive heat or open flame to ensure safety.

When applying this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. Additionally, it is advised against using this product in conjunction with other ointments, creams, sprays, or liniments, as such combinations may lead to unpredictable interactions.

Care should be taken to avoid application on irritated skin or in cases where excessive irritation develops. Bandaging the area after application is not recommended, nor should the product be used in conjunction with heating pads or devices, as this may increase the risk of skin irritation or burns.

After using the product, hands should be washed thoroughly with cool water to prevent unintentional transfer to sensitive areas. If the condition worsens or if symptoms persist for more than 7 days, it is essential to discontinue use and consult a healthcare professional for further evaluation and guidance.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product. It is essential to use the product only as directed and to keep it out of reach of children. The product is intended for external use only and should be kept away from excessive heat or flame.

During use, patients should avoid contact with the eyes or mucous membranes. It is contraindicated to apply the product to wounds or damaged skin, and it should not be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin or in cases where excessive irritation develops is also not recommended. Additionally, patients should refrain from bandaging the area after application and should not use the product with heating pads or devices.

Patients are advised to wash their hands with cool water after using the product. If the condition worsens or if symptoms persist for more than 7 days, patients should stop use and consult a healthcare professional.

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 Acuplus Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older should consult a physician prior to use. The use of this medication is not recommended for children under 2 years of age.

Geriatric Use

There is no specific information regarding the use of AcuPlus Pain Relief Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or interactions. It is advisable to consider the overall health status and comorbidities of geriatric patients when determining the appropriateness of this treatment.

Pregnancy

The product has not been evaluated for safety in pregnant women. Therefore, caution is advised as the effects on pregnancy are not established. There is no specific information available regarding risks to the fetus. Additionally, no specific dosage modifications for pregnant women are mentioned. It is recommended that healthcare professionals consult a physician before use in pregnant patients or those planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of AcuPlus Pain Relief Cream in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks 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 the product out of reach of children to prevent accidental ingestion or misuse. Patients should be instructed not to apply the product to wounds or damaged skin, as this may lead to adverse effects. It is important to inform patients that the product should not be used in conjunction with other ointments, creams, sprays, or liniments, as this may increase the risk of irritation or reduce efficacy.

Patients should also be cautioned against applying the product to irritated skin or if excessive irritation develops, as this could exacerbate their condition. Bandaging the area after application is not recommended, and patients should avoid using the product with heating pads or devices, as this may lead to increased absorption and potential side effects.

After using the product, patients should wash their hands thoroughly with cool water to prevent unintentional contact with sensitive areas. They should be advised to stop using the product and consult a healthcare professional if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be reminded to avoid contact with the eyes or mucous membranes during use to prevent irritation or injury.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat or flame to maintain its integrity.

After use, it is recommended to wash hands with cool water to ensure proper hygiene. Additionally, the product should be discarded after opening to prevent any potential contamination or degradation.

Additional Clinical Information

Patients should apply the medication to the affected area no more than three to four times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)