Calypxo Hp Pain Relief

Description

Calypxo HP is a pain relief cream formulated for topical application. Each container contains 4 ounces (113 grams) of the product. It is distributed by Enovachem Pharmaceuticals, located in Torrance, California, with the contact number (310) 320-0100. The product is identified by the National Drug Code (NDC) 76420-999-01.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains, and cramps.

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

Dosage and Administration

For adults, the medication should be applied directly to the affected area. Treatment may be repeated as necessary; however, it is important not to exceed a maximum frequency of 3 to 4 applications per day.

Contraindications

Use is contraindicated in the following situations:

If the product is swallowed, a physician should be consulted immediately. Additionally, it is advised that individuals who are pregnant or breastfeeding contact a physician prior to use to assess potential risks.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and mucous membranes to prevent irritation or injury. The treated areas should not be bandaged tightly or covered, as this may lead to adverse effects. Additionally, the application of heat, such as with a heating pad, is contraindicated.

This product should not be applied to open wounds or damaged skin, as this may exacerbate irritation or lead to complications. Users may experience a mild burning sensation upon application; however, if a severe burning sensation occurs, use should be discontinued immediately. Should symptoms persist for more than seven days, it is advised to discontinue use and consult a physician for further evaluation.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical advice promptly. Pregnant or breastfeeding individuals should consult a physician prior to use to assess any potential risks.

Side Effects

Patients may experience a mild burning sensation upon application of the product. In the event of a severe burning sensation, it is advised to discontinue use immediately. Should symptoms persist for more than seven days, patients are encouraged to discontinue use and consult a physician for further evaluation and guidance.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is important to consult a physician immediately.

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 contact their physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and management.

Potential symptoms of overdosage may vary depending on the specific circumstances and the individual’s health status. Therefore, a thorough assessment by a healthcare provider is essential to determine the appropriate course of action.

Management of overdosage should be guided by the physician's recommendations, which may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is advised to address any complications that may arise.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to consult their physician immediately for further guidance.

Additionally, it is important for healthcare providers to discuss the implications of the medication for patients who are pregnant or breastfeeding. Patients should be encouraged to contact their physician prior to using the medication in these circumstances to ensure safety for both the patient and the child.

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 at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered topically, with instructions for adults to apply it directly to the affected area. Applications may be repeated as necessary, but should not exceed 3-4 times daily. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)