Assured Ice Cold Topical Analgesic

Description

Assured ICE COLD is a topical analgesic gel formulated for the relief of pain. The product is presented in a net weight of 8 ounces (227 grams). It is distributed by Greenbrier International, Inc., located in Chesapeake, Virginia, 23320, and is manufactured in China.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in the following situations:

• Heating, microwaving, or adding to hot water is prohibited due to the risk of splattering and potential burns.

• Application to the eyes or directly on mucous membranes is contraindicated to prevent irritation or injury.

• Oral ingestion or nasal administration is not permitted.

• Application to wounds or damaged skin is contraindicated to avoid adverse effects.

• Bandaging of the skin after application is not recommended.

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.

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

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, persists for more than one week, or tends to recur. Regular monitoring of the patient's symptoms is recommended to assess the need for continued treatment or further medical evaluation.

Side Effects

Patients should be aware that the product is for external use only and should avoid contact with the eyes. It is advised that individuals consult a doctor before using the product 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 instructed to discontinue use and seek medical advice.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For infants and children under 2 years of age, it is recommended to consult a physician prior to use.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Assured Ice Cold Topical Analgesic Gel during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in women who are pregnant or may become pregnant, as the potential risks to fetal outcomes are not established. It is advisable to weigh the benefits against any unknown risks when recommending this product to pregnant patients.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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

Healthcare providers should emphasize the importance of not heating, microwaving, or adding the product to hot water, as these actions may cause splattering and result in burns. Patients must be instructed 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, it should not be applied to wounds or damaged skin, nor should it be bandaged.

Patients should be counseled to consult a doctor and discontinue use if their condition worsens, persists for more than one week, or tends to recur. This guidance is crucial for ensuring patient safety and effective use of the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a physician is advised prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Assured Ice Cold Topical Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)