Rocksauce Icy Cold Pain Relief

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

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:

• Not for use in children aged 5 years or younger.

• Use is contraindicated if not directed as specified.

• Heating, microwaving, or adding to hot water is prohibited, as this may cause splattering and result in burns.

• Avoid contact with eyes or application directly to mucous membranes.

• Do not administer orally or place in nostrils.

• Application to wounds or damaged skin is contraindicated.

Warnings and Precautions

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

Healthcare professionals are advised to counsel patients to consult a physician and discontinue use if any irritation develops. Additionally, it is recommended that individuals who are pregnant or breastfeeding seek guidance from a healthcare provider prior to use. Patients with sensitive skin should also consult a doctor before initiating treatment to ensure safety and efficacy.

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

It is imperative that patients are informed to stop using the product and consult their healthcare provider if irritation occurs, ensuring prompt evaluation and management of any potential side effects.

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 important to consult a doctor and discontinue use if any irritation occurs.

Additionally, patients are advised to seek guidance from a health professional before using the product if they are pregnant or breastfeeding. Those with sensitive skin should also consult a doctor prior to use 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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, careful consideration and professional guidance are recommended to ensure the safety of both the mother and the nursing infant.

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

Additionally, it is recommended to contact a poison control center or consult relevant clinical guidelines for further management strategies tailored to the specific circumstances of the overdose.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, 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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical 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 ensure its stability and efficacy. Proper storage conditions must be maintained, and the product should be kept in its original container to protect it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's integrity.

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 to consult a doctor and discontinue use if irritation occurs. It is recommended that patients seek advice from a health professional before use if they are pregnant or breastfeeding, or if they have sensitive skin. Additionally, the product should be kept out of reach of children, and in the event of accidental ingestion, medical help should be sought immediately or the Poison Control Center contacted. The product is not intended for use in children aged 5 years or younger.

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)