Rocksauce Ice

Description

RockSauce ICE is a topical pain relief cream designed to provide icy cold relief for sore muscles and joints. Each container has a net weight of 2.5 grams. The product is distributed by Rocktape, Inc. and is manufactured in China.

Uses and Indications

This drug is indicated for the relief of muscle and joint discomfort. It provides soothing cold therapy specifically designed to alleviate soreness in muscles and joints. The formulation acts as an icy cold pain relief cream, effectively soothing sore muscles and promoting comfort.

Dosage and Administration

The lotion should be applied liberally to the area of pain and massaged into the skin until fully absorbed. This application may be repeated 3 to 4 times daily, depending on the severity of symptoms.

This product is not indicated for use in children aged 5 years or younger.

Contraindications

Use of this product is contraindicated in the following situations:

Heating, microwaving, or adding the product to hot water or any container where heating may cause splattering is prohibited due to the risk of burns. Application in or around the eyes or directly on mucous membranes is contraindicated to prevent irritation or injury. The product should not be ingested or placed in the nostrils, as this may lead to adverse effects. Additionally, application to wounds or damaged skin is not recommended to avoid complications. Use of the product should strictly adhere to the provided directions; any deviation is contraindicated.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes, mucous membranes, or broken skin to prevent adverse reactions. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

The product should not be used in any manner other than as directed. Healthcare professionals are advised to consult a physician and discontinue use if any signs of irritation occur. Monitoring for irritation is essential to ensure patient safety and to mitigate potential complications associated with improper use.

Side Effects

Patients should be advised that the product is for external use only and must be kept away from the eyes, mucous membranes, and broken skin to prevent adverse reactions.

In clinical use, if irritation occurs, patients are instructed to consult a doctor and discontinue use of the product. This precaution is essential to ensure patient safety and to mitigate any potential adverse effects associated with the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 5 years of age should not use this medication. Safety and efficacy have not been established in this age group. Healthcare professionals are advised to consider alternative treatments for this population.

Geriatric Use

There is no specific information regarding the use of RockSauce ICE (menthol gel) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

There is currently no information available regarding the use of RockSauce ICE menthol gel during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution and consider the lack of data when prescribing this product to women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for ROCKSAUCE ICE menthol gel. Therefore, the effects on lactating mothers and breastfed infants are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

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 initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, 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 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

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of accidental ingestion of the product.

When discussing the proper use of this product, it is essential to emphasize that patients should not heat, microwave, or add the product to hot water, as this may cause splattering and result in burns. Patients must be informed that the product should not be used in the eyes or applied directly to mucous membranes. Additionally, it should not be taken by mouth or placed in the nostrils, nor should it be applied to wounds or damaged skin. Patients should be instructed to use the product only as directed and to avoid any other uses.

Healthcare providers should also counsel patients to consult a doctor and discontinue use if any irritation occurs. This guidance is crucial for ensuring the safe 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 temperature range of 68° to 77°F (20° to 25°C) to maintain its efficacy and integrity. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's quality during storage and transportation.

Additional Clinical Information

The product is intended for topical administration, with patients advised to apply the lotion liberally to the area of pain and massage until fully absorbed into the skin. This application should be repeated 3-4 times daily.

Clinicians should counsel patients on the following precautions: the lotion is for external use only and should not come into contact with the eyes, mucous membranes, or broken skin. Patients should avoid heating the product, as well as using it in or around the eyes or nostrils, and should not apply it to wounds or damaged skin. If irritation occurs, patients are advised to consult a doctor and discontinue use. The product should be kept out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

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

View product document (PDF)