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.

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. Healthcare professionals are advised to instruct patients to massage the lotion into the skin until fully absorbed. This application 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

The product should not be used 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. The product should not be ingested or placed in the nostril, as this may lead to adverse effects. Additionally, application to wounds or damaged skin is contraindicated to avoid complications. Use of the product 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. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management.

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 patient's condition is essential to determine the need for further intervention.

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 clinical practice, patients are advised to consult a doctor and discontinue use if their conditions persist for more than one week or if symptoms recur. This recommendation is based on clinical observations that suggest prolonged use without improvement may indicate a need for further medical evaluation.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 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.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals are encouraged to consider the absence of data when advising pregnant patients and to weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning 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 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 of these patients.

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 event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

Given the absence of detailed guidance, it is recommended that clinicians refer to established protocols for managing overdosage of similar agents, including symptomatic treatment and supportive measures. In cases of suspected overdosage, contacting a poison control center or seeking expert consultation may be prudent to ensure appropriate management strategies are employed.

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

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 to inform patients that they should consult a doctor and discontinue use if their condition persists for more than one week or if it recurs.

Providers should emphasize that the product should not be heated, microwaved, or added to hot water, as this may cause splattering and 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, it should not be applied to wounds or damaged skin.

Finally, healthcare providers should remind patients to use the product only as directed and to avoid any other uses.

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 application should 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 is important to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately. Patients are also advised to consult a doctor and discontinue use if symptoms persist for more than one week or recur.

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)