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 its analgesic properties. The gel is characterized by its clear and colorless appearance. Inactive ingredients include carbomer, triethanolamine, propylene glycol, purified water, methylparaben, and propylparaben, which contribute to the formulation's stability and efficacy.

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 mentioned in the available data.

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 may be applied to the affected area up to 3 to 4 times daily. It is important to ensure that the application does not exceed this frequency to maintain safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

Application in or near the eyes is prohibited due to the potential for irritation or injury. Additionally, the product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. It is also contraindicated to bandage the area tightly after application, as this could impede circulation and lead to further complications.

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 this may increase the risk of adverse effects. Additionally, it should not be used in conjunction with heating pads or other heating devices, as this may exacerbate skin irritation or lead to burns.

General precautions must be observed to ensure safe application. This product should not be applied in or near the eyes, nor should it be used on wounds or damaged skin. It is also advised not to bandage the area tightly after application, as this may impede circulation and lead to further complications.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if any redness or irritation develops at the application site. Monitoring for these signs is essential to ensure patient safety and effective treatment outcomes.

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 heating pads and heating devices, as this 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

The concurrent use of this medication with other topical pain relievers is contraindicated. Co-administration may increase the risk of adverse effects without providing additional therapeutic benefit.

Additionally, the use of heating pads or other heating devices in conjunction with this medication is not recommended. The combination may lead to enhanced absorption and increased risk of local irritation or systemic effects.

It is advised to avoid these combinations to ensure patient safety and optimal therapeutic outcomes.

Packaging & NDC

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

Pediatric Use

Pediatric patients 2 years of age and older are indicated for use of the product. The recommended application frequency is to the affected area no more than 3 to 4 times daily for both adults and pediatric patients within this age range.

It is essential to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before 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 prior to use to ensure appropriate management and consideration of any potential risks.

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 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 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.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to consult local poison control centers or relevant clinical guidelines for further assistance in managing overdose cases.

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 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 after use 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. Patients should apply the treatment to the affected area no more than 3 to 4 times daily.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)