Hielo Ardiente

Description

Hielo is a pharmaceutical compound characterized by its specific chemical properties. The molecular weight of Hielo is not specified in the provided data. The chemical formula is also not detailed. Hielo is available in a dosage form that is not explicitly mentioned. The appearance of Hielo is not described in the provided information. Further details regarding inactive ingredients or additional characteristics are not available.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application frequency is 3 to 4 times daily to the affected area. Prior to application, it is essential to cleanse and dry the skin thoroughly to ensure optimal adherence and effectiveness of the treatment.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

The product may be used in conjunction with wet or dry bandages, and the application can be complemented with the use of ice packs as needed to enhance therapeutic effects.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical attention should be sought by contacting a doctor or a Poison Control Center.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be used if the condition worsens. Should symptoms persist for more than five days or recur, the user must discontinue use and consult a physician. Application to open wounds or damaged skin is contraindicated. Additionally, the product should not be bandaged tightly, nor should it be used in conjunction with heating pads or heating devices.

Users are advised to utilize the product only as directed to ensure safety and efficacy.

In the event of accidental ingestion, immediate medical assistance should be sought by contacting a doctor or a Poison Control Center. If symptoms persist beyond five days or recur, it is essential to stop using the product and consult a healthcare professional.

Side Effects

Patients should be aware that the product is intended for external use only. It is crucial to avoid contact with the eyes, as this may lead to irritation or other adverse effects. In cases where the condition worsens, patients are advised to discontinue use and consult a physician.

If symptoms persist for more than five days or recur, it is recommended that patients stop using the product and seek medical advice. The product should not be applied to open wounds or damaged skin, as this may exacerbate the condition or lead to further complications. Additionally, patients should refrain from bandaging the area tightly, as this could impede circulation or cause discomfort.

The use of heating pads or other heating devices in conjunction with this product is not advised, as it may increase the risk of adverse reactions. These warnings are essential for ensuring the safe and effective use of the product.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 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 potential adverse effects or changes in efficacy, given the lack of targeted data for 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 are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 this medication and to take necessary precautions to ensure safety.

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

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. The container must be kept tightly closed to maintain the integrity of the product. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is recommended prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Hielo Ardiente, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)