Rocksauce Ice

Description

The product is a clear, colorless to slightly yellow liquid. It contains the active ingredient: insert active ingredient name here. Inactive ingredients include: insert inactive ingredients here. The product is packaged in a 12 oz container. The SPL code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor muscular discomfort.

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

Dosage and Administration

For the temporary relief of minor muscular discomfort, the lotion should be applied liberally to the affected area. The application should be followed by gentle massage until the lotion is fully absorbed into the skin. This process may be repeated 3 to 4 times daily, as needed.

It is important to note that this product is not intended for use in children aged 5 years or younger.

The lotion should be stored at a temperature range of 68 to 77°F (20 to 25°C) to maintain its efficacy.

Contraindications

Use is contraindicated in the following situations:

• Heating, microwaving, or adding to hot water or any container where heating may cause splattering, as this can result in burns.

• Application to the eyes or directly on mucous membranes is prohibited.

• Ingestion by mouth or placement in the nostril is not permitted.

• Application to wounds or damaged skin is contraindicated.

• Use is restricted to the specified directions; any other use is not advised.

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 individual should contact a Poison Control Center without delay.

Patients are advised to consult a healthcare professional and discontinue use if symptoms persist for more than one week or if they recur. This precaution is essential to ensure the safety and well-being of the patient.

Side Effects

Patients should be aware that the product is intended for external use only. It is crucial to avoid contact with the eyes, mucous membranes, or broken skin to prevent potential adverse reactions.

In the event that symptoms persist for more than one week or recur, patients are advised to consult a doctor and discontinue use. This precaution is essential to ensure safety and to address any underlying conditions that may require medical attention.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary 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, and caution is advised when considering treatment options for younger children.

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 information available regarding the use of ROCKSAUCE ICE menthol cream during pregnancy, including safety concerns, dosage modifications, or any special precautions. Healthcare professionals should consider this lack of data when advising pregnant patients or women of childbearing potential regarding the use of this product. It is recommended that the potential risks and benefits be carefully weighed in the context of individual patient circumstances.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

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 consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive care measures and consider symptomatic treatment as necessary.

For further guidance, consultation with a poison control center or a medical toxicologist is recommended to ensure appropriate management strategies are employed.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 if the product is accidentally ingested. It is important for patients to consult their doctor and discontinue use if their condition persists for more than one week or if it recurs.

Providers should instruct patients not to heat, microwave, or add the product to hot water or any container that may cause splattering, as this could result in burns. Additionally, patients should be cautioned against using the product in or around the eyes, directly on mucous membranes, by mouth, or in the nostrils.

Patients must also be informed not to apply the product to wounds or damaged skin. Emphasizing the importance of following directions, healthcare providers should remind patients not to use the product in any manner other than as directed.

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 integrity and efficacy.

Care should be taken to avoid heating the product; it must not be heated, microwaved, or placed in hot water. Additionally, it should not be stored in any container that may cause heating water to splatter, as this could result in burns. Proper handling and storage conditions are crucial to ensure the safety and effectiveness of the product.

Additional Clinical Information

No further data are available.

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)