Ice Cold Analgesic

Description

ICE COLD ANALGESIC GEL is a topical analgesic formulated for the relief of pain. The product is presented in a net weight of 8 ounces (227 grams).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with various conditions, including arthritis, simple backache, strains, bruises, sports injuries, and sprains. It provides cooling, penetrating relief to alleviate discomfort associated with these conditions.

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 may be applied to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician before use.

Contraindications

The product is contraindicated in the following situations:

• Co-administration with other topical pain relievers is not recommended due to the potential for increased irritation or adverse effects.

• Use with heating pads or heating devices is contraindicated as it may lead to excessive heat and skin damage.

• Application in or near the eyes is prohibited to prevent serious ocular injury.

• The product should not be applied to wounds or damaged skin to avoid exacerbating the injury or causing infection.

• Tight bandaging after application is contraindicated to ensure proper circulation and prevent skin irritation.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

It is imperative to avoid concurrent use with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, the application of this product in conjunction with heating pads or other heating devices is contraindicated, as it may lead to excessive skin irritation or burns.

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, or if symptoms resolve and then recur within a few days. Patients should also be instructed to contact their healthcare provider if they experience any redness or irritation at the application site.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, if redness or irritation develops, medical advice should be sought.

Drug Interactions

The concurrent use of this medication with other topical pain relievers is contraindicated. Co-administration may increase the risk of adverse effects and diminish the therapeutic efficacy of the individual agents.

Additionally, the application 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 that healthcare professionals monitor patients closely for any signs of adverse reactions when considering the use of this medication alongside other topical agents or heating methods.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 this product out of the reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed not to use this product in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, they should avoid using heating pads or other heating devices while using this product, as this could lead to increased irritation or burns.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms recur within a few days after stopping the product. Patients should also be advised to stop use and seek medical advice if they experience any redness or irritation.

It is important to remind patients that this product should not be applied in or near the eyes, nor should it be used on wounds or damaged skin. Furthermore, patients should be cautioned against tightly bandaging the area where the product is applied, as this may exacerbate irritation or other side effects.

Storage and Handling

The product is supplied in a tightly closed container and should be stored at a controlled room temperature of 20 to 25°C (68 to 77°F). It is essential to avoid exposure to heat or open flame; therefore, the product must not be used, poured, spilled, or stored in proximity to such sources.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before use. 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 Ice Cold Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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