Universal Ice Cold Analgesic

Description

ICE COLD ANALGESIC GEL is presented in a dosage form of a topical gel, with a net weight of 8 fluid ounces (227 grams). 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. It provides cooling, penetrating relief to alleviate discomfort.

There are no teratogenic or nonteratogenic effects associated with this drug as per 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. For children under 2 years of age, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Application near the eyes is prohibited due to the potential for irritation or injury. The product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Additionally, tight bandaging of the area where the product is applied is contraindicated to prevent compromised circulation and potential skin damage.

Warnings and Precautions

For external use only. This product should not be used in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, the application of heating pads or other heating devices is contraindicated, as it may exacerbate local irritation or discomfort.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult their physician under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Furthermore, patients should be instructed to stop using the product if any redness or irritation develops at the application site. Regular monitoring of the patient's response to treatment is recommended to ensure safety and efficacy.

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 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 no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 context of overdosage, it is important to note that no specific information regarding overdosage has been provided in the available documentation. Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose based on the pharmacological profile of the medication in question.

In the absence of detailed overdosage information, it is recommended that healthcare providers monitor patients closely for any unusual symptoms or adverse reactions that may arise. Should an overdose be suspected, standard emergency protocols should be initiated, including supportive care and symptomatic treatment as necessary.

Healthcare professionals are encouraged to consult relevant clinical guidelines and toxicology resources for further management strategies in cases of suspected overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 patients to understand that they should discontinue use and consult a healthcare provider 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 their doctor if they experience any redness or irritation. Additionally, healthcare providers should emphasize that the product should not be used in or near the eyes, nor should it be applied to wounds or damaged skin. Patients should be cautioned against tightly bandaging the area where the product is applied.

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 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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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