Ice Analgesic

Description

ICE Analgesic Gel is a topical formulation designed for pain relief. The product is packaged in a net weight of 8 ounces (227 grams). It is distributed by Filo America, located at P.O. Box 23592, Los Angeles, CA 90023. The gel is developed in the United States, with manufacturing conducted in the People's Republic of China (PRC).

Uses and Indications

This drug is indicated for the temporary relief of minor muscle aches and pains.

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

Dosage and Administration

For the temporary relief of minor muscle aches and pains, this product is indicated for use in adults and children aged 2 years and older. The gel should be applied directly to the affected area and massaged into the skin until fully absorbed. This application may be repeated 3 to 4 times daily as needed.

It is important to note that this product is not recommended for use in children under 2 years of age. Healthcare professionals should ensure that patients are aware of this restriction when advising on treatment options.

Contraindications

Use of this product is contraindicated in the following situations:

Heating the product is prohibited, including methods such as microwaving or adding it to hot water, as this may lead to splattering and potential burns. The product should not be applied to the eyes or directly on mucous membranes, nor should it be ingested or placed in the nostrils. Additionally, application to wounds or damaged skin is contraindicated, and the product should not be bandaged on the skin.

Warnings and Precautions

For external use only; direct contact with the eyes should be avoided to prevent irritation or injury. Healthcare professionals should advise patients to consult a physician prior to use if they have a cough associated with smoking, excessive phlegm, asthma, emphysema, or a persistent or chronic cough.

In the event of accidental ingestion, it is imperative to seek professional medical assistance or contact a Poison Control Center immediately to ensure appropriate management and care.

Patients should be instructed to discontinue use and consult their healthcare provider if their condition worsens, persists for more than one week, or tends to recur. This precaution is essential to prevent potential complications and ensure patient safety.

No specific laboratory tests are recommended for monitoring in conjunction with this product.

Side Effects

Patients using this product should be aware that it is intended for external use only and must avoid contact with the eyes. It is recommended that individuals consult a doctor prior to use if they have a cough associated with smoking, excessive phlegm, asthma, emphysema, or a persistent or chronic cough.

In the event that the condition worsens, persists for more than one week, or tends to recur, patients are advised to discontinue use and seek medical consultation.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 years and older, the recommended application involves massaging the gel into the painful area until fully absorbed into the skin. This process may be repeated 3 to 4 times daily.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data in pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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 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 professional assistance or contact a Poison Control Center immediately in the event of accidental ingestion of this product.

Patients should be informed about specific precautions when using this product. They must not heat, microwave, or add the product to hot water or any container where heating water may cause splattering, which could result in burns. It is essential to instruct patients to avoid using the product in or around the eyes, directly on mucous membranes, or taking it by mouth or placing it in the nostrils. Additionally, patients should not apply the product to wounds or damaged skin, nor should they bandage the skin after application.

Healthcare providers should encourage patients to consult a doctor and discontinue use if their condition worsens, persists for more than one week, or tends to recur.

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. Freezing the product is not permitted, as it may compromise its quality. Additionally, it is important to discard the product after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically. For adults and children aged 2 years and older, it should be applied to the painful area and massaged into the skin until fully absorbed. This application can be repeated 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 Ice Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)