Rocksauce Ice

Description

RockSauce ICE is a topical formulation distributed by Rocktape, Inc. It is packaged in a net weight of 3 ounces. The product is manufactured in China.

Uses and Indications

This drug is indicated for the relief of discomfort associated with cold, sore muscles, and joints.

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

Dosage and Administration

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

For optimal storage, the lotion should be kept 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:

• The product should not be used if irritation occurs.

• Consultation with a healthcare professional is advised prior to use in individuals who are pregnant or breastfeeding.

• Individuals with sensitive skin should seek medical advice before using this product.

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 local Poison Control Center should be contacted without delay.

Should irritation occur during use, it is advisable to consult a healthcare professional prior to continued use, particularly for individuals who are pregnant, breastfeeding, or have sensitive skin. This precaution ensures the safety and well-being of both the user and the developing fetus or nursing infant.

Side Effects

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

In clinical practice, if irritation occurs, it is advised that patients consult a healthcare professional. Additionally, individuals who are pregnant, breastfeeding, or have sensitive skin should seek medical advice prior to use and discontinue the product if any irritation develops.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. 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 should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 administering this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects is advisable, given the lack of established guidelines for this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. It is recommended to discontinue use if any irritation occurs. Additionally, women who are breastfeeding should seek advice from a health professional prior to use. The safety of this medication during pregnancy and lactation has not been established, and caution is advised.

Lactation

Lactating mothers should consult a healthcare professional before using this medication, especially if they are pregnant or breastfeeding. If irritation occurs, it is advised to discontinue use and seek medical advice. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for the product associated with SPL code 90375-7.

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.

Additionally, patients should be informed to consult a health professional prior to use if they experience any irritation, are pregnant, or are breastfeeding. It is also recommended that patients with sensitive skin discuss their condition with a healthcare provider before using the product to ensure safety and appropriateness.

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 storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The product is administered topically, 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 that the lotion is for external use only and to avoid contact with eyes, mucous membranes, or broken skin. Patients should be instructed to consult a doctor and discontinue use if irritation occurs. It is recommended that individuals who are pregnant, breastfeeding, or have sensitive skin seek professional advice before use. Additionally, the product should be kept out of reach of children, and in the event of accidental ingestion, medical help or a Poison Control Center should be contacted immediately.

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)