Universal Ice Cold Analgesic

Description

ICE COLD ANALGESIC GEL is presented in a dosage form of a topical gel, contained in an 8 fluid ounce (237 mL) bottle. The formulation is designed for local application to provide analgesic effects.

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 arthritis, simple backache, strains, bruises, sports injuries, and sprains.

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

Dosage and Administration

Healthcare professionals should ensure that the affected area is thoroughly cleaned prior to the application of the product. The recommended dosage for adults and children aged 2 years and older is to apply the product to the affected area no more than 3 to 4 times daily. Care should be taken to adhere to this frequency to optimize therapeutic outcomes while minimizing the risk of adverse effects.

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 damage to ocular tissues. Additionally, the product should not be applied to wounds or damaged skin, as this may exacerbate irritation or hinder healing. It is also contraindicated to bandage tightly after application, as this could lead to increased pressure and potential adverse effects.

Warnings and Precautions

For external use only. The product should not be used in conjunction with other topical pain relievers, nor should it be applied while using heating pads or other heating devices, as this may increase the risk of adverse effects.

Healthcare professionals should advise patients to discontinue use and seek medical attention 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 any redness or irritation develops at the application site, patients should be instructed to stop use and consult a healthcare provider.

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

Patients should be aware that the product is intended for external use only. It is contraindicated for use in conjunction with other topical pain relievers, as well as with heating pads or heating devices, due to the potential for increased adverse reactions.

In clinical practice, patients are advised to discontinue use 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 immediate cessation 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 Universal Ice Cold Analgesic (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 3 to 4 times daily to the affected area for both adults and pediatric patients within this age range.

Caution is advised to keep the product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 potential 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 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 on 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, 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 is advisable to ensure patient safety and optimal therapeutic outcomes.

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 amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for healthcare providers to instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days, or if symptoms reappear shortly after cleaning up.

Patients should also be informed to stop using the product and consult a healthcare professional if they experience any redness or irritation. Additionally, when using this product, patients must be cautioned against applying it in or near the eyes, on wounds, or on damaged skin. They should also be advised not to bandage the area tightly after 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 protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

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

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