Rocksauce Icy Cold Pain Relief

Description

The product is a clear, colorless to pale 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 insert packaging details here.

Uses and Indications

This drug is indicated for the relief of discomfort associated with cold to 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 may 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 of this product is contraindicated in the following situations:

• The product is not intended for use in children aged 5 years or younger.

• Administration should strictly adhere to the provided directions; any deviation is contraindicated.

• Heating, microwaving, or adding the product to hot water or any container that may cause splattering, leading to burns, is prohibited.

• Direct application to the eyes or mucus membranes is contraindicated.

• Oral ingestion or placement in the nostrils is not permitted.

• Application to wounds or damaged skin is contraindicated.

Warnings and Precautions

For external use only; contact with eyes, mucous membranes, or broken skin must be avoided to prevent adverse effects.

It is imperative that this product is used strictly as directed. Users should refrain from the following actions while using this product: heating, microwaving, or adding it to hot water, as these practices may lead to splattering and potential burns. Additionally, the product should not be applied in or around the eyes, directly on mucous membranes, ingested, or placed in the nostrils. It is also contraindicated for application on wounds or damaged skin.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Users are advised to discontinue use and consult a healthcare professional if any irritation occurs. Pregnant or breastfeeding individuals should seek guidance from a healthcare provider prior to use. Furthermore, individuals with sensitive skin are encouraged to consult a physician before using this product.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes, mucous membranes, or broken skin. In clinical practice, it is advised that patients consult a doctor and discontinue use if any irritation occurs.

Additionally, it is recommended that individuals who are pregnant or breastfeeding seek guidance from a health professional prior to use. Patients with sensitive skin should also consult a doctor before using the product to ensure safety and minimize the risk of adverse reactions.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 5 years of age should not use this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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 and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are breastfeeding. 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 the use of this medication during lactation.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert text. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any symptoms observed, is vital for ongoing management and potential reporting requirements.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and 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 the Poison Control Center in the event of accidental ingestion. It is important to emphasize that this product is not intended for use in children aged 5 years or younger.

Patients should be instructed to use the product strictly as directed and to avoid any misuse. They should be cautioned against heating the product, microwaving it, or adding it to hot water, as these actions may lead to splattering and potential burns. Additionally, patients must be informed not to apply the product to the eyes, directly on mucous membranes, or to ingest it by mouth or place it in the nostrils. The product should not be applied to wounds or damaged skin.

Healthcare providers should recommend that patients consult a doctor and discontinue use if any irritation occurs. It is also advisable for patients to seek guidance from a health professional before using the product if they are pregnant or breastfeeding. Furthermore, patients with sensitive skin should be encouraged to consult a doctor prior to use 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 stability. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

Patients should apply the lotion liberally to the area of pain and massage until fully absorbed into the skin, with a recommended frequency of 3-4 times daily. Clinicians should advise patients to consult a doctor and discontinue use if irritation occurs. Additionally, patients are encouraged to seek guidance from a health professional before use if they are pregnant or breastfeeding, or if they have sensitive skin.

Drug Information (PDF)

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

View product document (PDF)