Ice Cold Analgesic

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the management of musculoskeletal pain and discomfort. It is formulated as an Ice Cold Analgesic Gel, designed for topical application to provide localized relief. The product is also referred to as DT for your DailyTouch and Gel Frio Antimuscular.

There are no teratogenic or nonteratogenic effects associated with this drug, indicating a favorable safety profile for use in the indicated patient populations.

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. It is contraindicated for use in children under 2 years of age.

The recommended route of administration is topical. Healthcare professionals should instruct patients to apply the gel liberally to the affected area and massage it into the skin until fully absorbed. This application may be repeated 3 to 4 times daily, as needed, to achieve the desired relief.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental ingestion, it is imperative to seek professional assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only; contact with eyes should be strictly avoided. 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.

When utilizing this product, it is imperative to adhere to the following precautions: do not heat, microwave, or add the product to hot water or any container that may cause splattering, which could result in burns. The product should not be applied to the eyes or directly on mucous membranes, ingested, or placed in the nostrils. Additionally, it should not be applied to wounds or damaged skin, nor should it be bandaged.

Patients should be instructed to consult a healthcare provider and discontinue use if their condition worsens, persists for more than one week, or tends to recur. In the event of accidental ingestion, immediate professional assistance should be sought, or the local Poison Control Center should be contacted.

Side Effects

Patients should be advised that the product is for external use only and must be kept away from the eyes to prevent irritation or injury.

In clinical practice, it is recommended that patients consult a doctor and discontinue use if their condition worsens, persists for more than one week, or tends to recur. These precautions are essential to ensure patient safety and to avoid potential complications associated with prolonged use or inappropriate application of the product.

Drug Interactions

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

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 not use this medication. For children aged 2 years and older, the recommended application involves liberal use on the painful area, followed by gentle massage until the gel is 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

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 these patients to ensure safety and efficacy.

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 event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely and provide supportive care as needed. It is essential to assess the patient's clinical status and implement standard emergency protocols for overdose situations.

In the absence of detailed guidance, practitioners should consider consulting local poison control centers or relevant medical authorities for further assistance in managing potential overdosage 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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with the medication and to take necessary precautions to ensure safety.

In the event of accidental ingestion, healthcare providers should instruct patients to seek professional assistance or contact a Poison Control Center immediately. Emphasizing the importance of prompt action in such situations can help mitigate potential harm.

Storage and Handling

The product is supplied in configurations that ensure optimal handling and storage. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is imperative to keep the product out of reach of children.

Special handling precautions must be observed. The product must not be heated, microwaved, or added to hot water or any container that may cause splattering, as this could result in burns. Adhering to these guidelines will help ensure the product's integrity and safety during use.

Additional Clinical Information

The product is administered topically, with the recommended application for adults and children aged 2 years and older being to apply liberally to the painful area and massage until the gel is absorbed into the skin. This process may be repeated 3 to 4 times daily.

Clinicians should counsel patients to keep the product out of reach of children. In the event of accidental ingestion, professional assistance or contact with a Poison Control Center is advised. Patients are also encouraged to consult a doctor and discontinue use if their condition worsens, persists for more than one week, or tends to recur.

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.

View product document (PDF)