Medpride Cold Ice Analgesic Gel

Description

The product is a topical analgesic gel identified by SPL code 34089-3. It contains menthol as the active ingredient, providing analgesic properties. The gel is clear and colorless in appearance. Inactive ingredients include carbomer, triethanolamine, propylene glycol, purified water, methylparaben, propylparaben, and sodium hydroxide.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in muscles and joints associated with various conditions, including simple backaches, strains, sprains, sports injuries, arthritis, and bruises.

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

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily.

Contraindications

Use is contraindicated in the following situations:

• Application in or near the eyes is prohibited due to the potential for irritation or damage to ocular tissues.

• The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or hinder healing.

• Tight bandaging of the area where the product is applied is contraindicated, as it may lead to increased pressure and potential adverse effects.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is intended solely for topical application and should not be ingested. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

The use of this product is contraindicated in conjunction with other topical pain relievers, as well as with heating pads or any heating devices, due to the potential for increased adverse effects.

General precautions must be observed to ensure safe application. This product should not be used in or near the eyes, nor should it be applied to wounds or damaged skin. Additionally, it is important to avoid tightly bandaging the area of application, as this may exacerbate irritation or other adverse reactions.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, or the development of redness or irritation at the application site. Monitoring for these signs is essential to ensure patient safety and effective management of treatment.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated for use in conjunction with other topical pain relievers or with heating pads and heating devices, as these combinations may increase the risk of adverse reactions.

In clinical practice, patients are advised to stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, the development of redness or irritation at the application site warrants discontinuation of use and medical consultation.

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated due to the potential for increased local irritation or adverse effects. It is essential to avoid the simultaneous use of heating pads or other heating devices, as this may enhance the risk of skin irritation or burns.

Healthcare professionals should monitor patients for any signs of adverse reactions when considering the use of this medication in conjunction with other topical agents or heat sources.

Packaging & NDC

Below are the non-prescription pack sizes of Medpride Cold Ice Analgesic Gel (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use this medication. The recommended application frequency is not more than 3 to 4 times daily to the affected area.

It is crucial to keep this medication out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center for guidance.

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. 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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 drug 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 text.

Patient Counseling

Healthcare providers should advise patients to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to instruct patients not to use the product in or near the eyes, as this could lead to irritation or injury.

Patients should be informed that the product should not be applied to wounds or damaged skin, and they should avoid tightly bandaging the area where the product is applied. Providers should emphasize the importance of monitoring their condition and to stop use and consult a doctor if the condition worsens.

Additionally, patients should be counseled to discontinue use and seek medical advice if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised to stop using the product and consult a healthcare professional if any redness or irritation develops following application.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to ensure optimal stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically and is indicated for use in adults and children aged 2 years and older, with a recommended application frequency of no more than 3 to 4 times daily to the affected area.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if any redness or irritation develops.

Drug Information (PDF)

This file contains official product information for Medpride Cold Ice Analgesic Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)