Rocksauce Ice

Description

The product is identified by the SPL code 34089-3 and is presented as a white to off-white powder. The formulation includes several inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. It is packaged in a container designed to protect the contents from moisture and light. The chemical name is not specified in the provided information.

Uses and Indications

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

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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 accompanied by a 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 is contraindicated due to the risk of burns. Application to the eyes or directly on mucous membranes is prohibited to prevent irritation or injury. Ingestion by mouth or placement in the nostril is contraindicated to avoid potential adverse effects. Application to wounds or damaged skin is not recommended to prevent complications. Additionally, use should strictly adhere to the provided directions to ensure safety and efficacy.

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. This precaution is critical to ensure appropriate management and minimize potential harm.

Patients should discontinue use and consult their healthcare provider if symptoms persist for more than one week or if they recur. Continuous monitoring of the condition is essential to determine the need for further medical evaluation.

Emergency medical help must be obtained if accidental ingestion occurs, reinforcing the importance of prompt action in such situations.

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 of the product. 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

Elderly patients should be aware that this medication is not indicated for use in children aged 5 years or younger. It is essential for geriatric patients to consult a healthcare provider if their condition persists for more than one week or if symptoms recur. Discontinuation of the medication may be necessary under these circumstances, and close monitoring is advised to ensure safety and efficacy 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. It is recommended that the potential risks and benefits be carefully weighed before prescribing this product to individuals who are pregnant or may become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 context of overdosage, it is important to note that there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to exercise caution and consider the individual patient's circumstances when faced with a potential overdosage scenario.

In the absence of detailed guidance, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions that may arise. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

In cases of suspected overdosage, it is prudent to consult local poison control centers or relevant medical authorities for further assistance and guidance on management strategies.

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 fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, it is crucial to seek medical help or contact a Poison Control Center immediately.

Healthcare providers should instruct patients to consult a doctor and discontinue use if their condition persists for more than one week or if it recurs. It is important to emphasize that when using this product, patients should not heat, microwave, or add it to hot water or any container where heating water may cause splattering, as this could result in burns.

Patients must be cautioned against using the product in or around the eyes, directly on mucous membranes, by mouth, or in the nostrils. Additionally, they should not apply the product to wounds or damaged skin. It is essential to remind patients to use the product only as directed and not to deviate from the recommended usage instructions.

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

The medication is administered topically, with patients advised to apply it liberally to the painful area and massage until absorbed into the skin. This process may be repeated 3-4 times daily.

Clinicians should counsel patients that the product is for external use only and must be kept away from the eyes, mucous membranes, and broken skin. It should also be stored out of reach of children. In the event of accidental ingestion, patients are instructed to seek medical assistance or contact a Poison Control Center immediately. If symptoms persist for more than one week or recur, patients should consult a doctor and discontinue use.

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)