Raw Ice

Description

RAW™ ICE is a roll-on gel formulation designed for the relief of pain associated with arthritis, muscle, and joint discomfort. This product is presented in a 3 fluid ounce (89 mL) container and is composed of 100% natural ingredients, emphasizing its suitability for users seeking a natural approach to pain management.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with muscle sprains, muscle strains, neck and back aches, sore joints, arthritis, cramps, and bruises.

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

Dosage and Administration

For adults and children aged 6 years and older, the gel should be administered as follows:

The container must be shaken well prior to use. The skin over the affected area should be cleaned thoroughly. A liberal amount of the gel should then be applied directly onto the skin, ensuring it is absorbed completely. This application may be repeated as necessary, but should not exceed four times daily. The gel may also be applied before or after physical activity to enhance its effectiveness.

For children under 6 years of age, it is recommended to consult a healthcare professional for appropriate guidance on use.

Contraindications

Application is contraindicated on open wounds or damaged skin, as well as on irritated skin. The product is for external use only and is flammable; it should be kept away from open flames or extreme heat. Tight bandaging is not recommended, and the product should not be used in conjunction with heating pads or other topical ointments, creams, sprays, or liniments. Additionally, consultation with a healthcare professional is advised for pregnant or breastfeeding individuals prior to use.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from open flames or extreme heat sources. It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a poison control center without delay.

When utilizing this product, it is essential to adhere strictly to the directions provided. Users should avoid contact with the eyes and mucous membranes, and the product must not be applied to open wounds or damaged skin. Bandaging should not be done tightly, and the product should not be used in conjunction with heating pads or other topical ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and thorough handwashing is required after each use to prevent unintended contact.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, or if any irritation occurs. Additionally, it is recommended that individuals who are pregnant or breastfeeding consult a healthcare professional prior to using this product.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from open flames or extreme heat. It is crucial to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a poison control center.

When using this product, patients are advised to follow the instructions carefully. It is important to avoid contact with the eyes and mucous membranes, and the product should not be applied to open wounds or damaged skin. Patients should refrain from tightly bandaging the area after application and should not use the product in conjunction with heating pads or other ointments, creams, sprays, or liniments. Additionally, the product should not be applied to irritated skin, and hands should be washed thoroughly after each application.

Patients are instructed to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Any occurrence of irritation should also prompt a consultation with a health professional. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before using this product. It is recommended to store the product at room temperature.

Drug Interactions

The use of this medication is contraindicated with heating pads or other topical formulations, including ointments, creams, sprays, or liniments. Co-administration may lead to adverse effects due to enhanced absorption or localized irritation.

No specific interactions with laboratory tests have been identified. Therefore, routine monitoring of laboratory parameters is not required when using this medication.

Packaging & NDC

Below are the non-prescription pack sizes of Raw Ice (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years and older may apply a liberal amount of gel directly to the skin over the affected area until fully absorbed. This application may be repeated as necessary, not exceeding four times daily.

For children under 6 years of age, it is advised to consult a healthcare professional before use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring informed decision-making for both maternal and fetal health.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the patient's clinical presentation. Continuous evaluation and appropriate interventions should be implemented as necessary to ensure patient safety and recovery.

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

Healthcare providers should advise patients that the product is intended for external use only and must be kept away from open flames or extreme heat due to its flammable nature. It is essential to keep the product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

When using the product, patients should be reminded to follow the directions provided and to avoid contact with the eyes and mucous membranes. They should not apply the product to open wounds or damaged skin, and it is important to avoid tight bandaging of the area where the product is applied. Additionally, patients should not use the product in conjunction with heating pads or other ointments, creams, sprays, or liniments, and should refrain from applying it to irritated skin.

Patients should be counseled to wash their hands thoroughly after each application to prevent unintentional contact with other areas of the body. They should be instructed to stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than seven days, if symptoms clear up and then recur within a few days, or if any irritation occurs.

For patients who are pregnant or breastfeeding, it is important to recommend that they consult a healthcare professional before using the product. Finally, advise patients to store the product at room temperature to maintain its efficacy.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is kept away from open flames and extreme heat due to its flammable nature.

To maintain safety, the product must be kept out of reach of children. Healthcare professionals are advised to wash their hands thoroughly after each application to prevent any unintended exposure. Additionally, any unused product should be discarded after opening, if applicable, to ensure proper safety and efficacy.

Additional Clinical Information

The product is administered topically for both adults and children aged 6 years and older. Patients should shake the gel well, clean the affected skin area, and apply a liberal amount directly onto the skin until fully absorbed. This application may be repeated as necessary, not exceeding four times daily, and can be done before or after physical activity. For children under 6 years of age, consultation with a healthcare professional is advised.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Raw Ice, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)