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Raw Ice

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 34.79 g/1 L
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
January 30, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 34.79 g/1 L
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
January 30, 2013
Manufacturer
Raw Health International, LLC
Registration number
part348
NDC root
55413-2500
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

RAW ICE is an all-natural cooling pain reliever designed to temporarily alleviate minor pain associated with various conditions, including muscle sprains, muscle strains, neck and back aches, sore joints, arthritis, cramps, and bruises. This product is available in a 3 fl oz (89 mL) bottle and is manufactured by RAW HEALTH INTERNATIONAL.

If you're looking for a soothing option to help manage discomfort, RAW ICE may be a suitable choice for you. For those who prefer warming relief, you might also consider trying RAW-HEAT.

Uses

You can use this medication to temporarily relieve minor pain from various conditions. It helps with discomfort caused by muscle sprains and strains, neck and back aches, sore joints, arthritis, cramps, and bruises.

It's important to note that this medication has not been associated with teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects. This makes it a safer option for managing your minor pain without the worry of these specific risks.

Dosage and Administration

Before using this gel, make sure to shake it well. Start by cleaning the area of skin where you plan to apply the gel. Then, apply a generous amount directly onto the affected area and gently rub it in until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times in a single day. Additionally, you can use the gel before or after any physical activity to help with discomfort.

If you are considering using this gel for a child under 6 years old, it’s important to consult a healthcare professional first to ensure it’s safe and appropriate for them.

What to Avoid

You should avoid using this product in several important ways to ensure your safety. Do not apply it with a heating pad or alongside other ointments, creams, sprays, or liniments, as this can lead to adverse effects. It's also crucial not to use it on irritated skin, open wounds, or damaged areas, and you should keep it away from your eyes and mucous membranes. Additionally, avoid tightly bandaging the area where you apply the product. Following these guidelines will help you use the product safely and effectively.

Side Effects

You should be aware that this product is for external use only and is flammable, so keep it away from open flames or extreme heat. Avoid using it with heating pads or other topical products like ointments, creams, sprays, or liniments, and do not apply it to irritated skin.

If you notice that your condition worsens, symptoms last longer than 7 days, or if they clear up and then come back within a few days, you should stop using the product and consult a health professional. Additionally, if you experience any irritation, discontinue use. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product.

Warnings and Precautions

This product is for external use only and is flammable, so be sure to keep it away from open flames or extreme heat. Always keep it out of reach of children. If swallowed, seek medical help or contact a poison control center immediately.

When using this product, follow the instructions carefully. Avoid contact with your eyes and mucous membranes, and do not apply it to open wounds or damaged skin. It’s important not to use it with heating pads or other topical products like ointments or creams, and make sure to wash your hands thoroughly after each application. If your condition worsens, symptoms last more than 7 days, or if irritation occurs, stop using the product and consult a healthcare professional. If you are pregnant or breastfeeding, check with your doctor before use. Store the product at room temperature.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a poison control center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you receive personalized advice that considers your health and the well-being of your baby. Always prioritize open communication with your healthcare provider to make informed decisions about your care during this time.

Pediatric Use

When using this gel for children aged 6 years and older, you should shake the bottle well and clean the skin before applying a generous amount directly to the affected area. Make sure to rub it in until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times a day. It can also be used before or after physical activities.

If your child is under 6 years old, it’s important to consult a healthcare professional before using this product. This ensures that you get the best advice tailored to your child's specific needs.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

However, it's always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and ensure that any medications you take are safe for your liver health.

Drug Interactions

It's important to be cautious when using certain medications together. For instance, you should avoid using this medication with heating pads or other topical products like ointments, creams, sprays, or liniments, as this can lead to unwanted effects.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter products, to ensure your safety and the effectiveness of your treatment. They can help you understand potential interactions and guide you on the best practices for your health.

Storage and Handling

To ensure the safety and effectiveness of the product, store it at room temperature, away from any open flames or extreme heat, as it is flammable. Always keep it out of reach of children to prevent accidental use. After each application, make sure to wash your hands thoroughly to maintain hygiene. Remember to discard the product after opening to avoid any potential risks.

Additional Information

You should apply this medication topically, which means you will put it directly on your skin. For adults and children aged 6 years and older, shake the bottle well, clean the skin, and then apply a generous amount of gel to the affected area until it is absorbed. You can repeat this process as needed, but do not apply it more than four times a day. It can also be used before or after physical activity. If you are considering using it for a child under 6 years old, please consult a healthcare professional first.

FAQ

What is RAW ICE?

RAW ICE is an all-natural cooling pain reliever designed to temporarily relieve minor pain associated with muscle sprains, strains, neck/back aches, sore joints, arthritis, cramps, and bruises.

How should I use RAW ICE?

For adults and children 6 years and older, shake well, clean the skin, and apply a liberal amount of gel directly on the affected area until absorbed. You can repeat this up to 4 times daily.

Are there any precautions I should take when using RAW ICE?

Yes, avoid contact with eyes and mucous membranes, do not apply to open wounds or damaged skin, and do not bandage tightly. Also, do not use with heating pads or other ointments.

What should I do if my condition worsens or irritation occurs?

Stop using RAW ICE and consult a health professional if your condition worsens, symptoms persist for more than 7 days, or if irritation occurs.

Is RAW ICE safe for children?

RAW ICE is for adults and children 6 years and older. For children under 6, consult a health care professional before use.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health care professional before using RAW ICE.

Where can I find more information about RAW ICE?

You can visit the manufacturer's website at www.rawhealthintl.com for more information.

Packaging Info

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

Packaging configurations for Raw Ice.
Details

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)

Description

This product is an all-natural cooling pain reliever formulated to address muscle strains, joint sprains, and neck or back aches, among other discomforts. It is available in a dosage form of 3 fluid ounces (89 mL).

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 shaken well before use. The affected area of the skin must be cleaned prior to application. A liberal amount of the gel should be applied directly onto the skin over the affected area and gently massaged until fully absorbed. 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 prior to use.

Contraindications

The product is contraindicated in the following situations:

Application with a heating pad or other topical agents such as ointments, creams, sprays, or liniments is prohibited due to the potential for increased irritation or adverse effects. The product should not be applied to irritated skin, as this may exacerbate the condition. Contact with eyes and mucous membranes must be avoided to prevent irritation or injury. Additionally, the product is contraindicated for use on open wounds or damaged skin, as this could lead to complications. Tight bandaging of the area where the product is applied is also not recommended, as it may hinder proper absorption and increase the risk of adverse reactions.

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. In the event of accidental ingestion, 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. Additionally, it is advised not to bandage the area tightly after application.

This product should not be used in conjunction with heating pads or other topical ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated. Thorough handwashing is recommended after each use to prevent unintended exposure.

Users are advised to discontinue use and consult a healthcare professional if the 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. Pregnant or breastfeeding individuals should seek guidance from a healthcare professional prior to use. The product should be stored at room temperature to maintain its efficacy.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Warnings indicate that the product is for external use only and is flammable; therefore, it should be kept away from open flames or extreme heat. It is crucial not to use the product in conjunction with heating pads or other ointments, creams, sprays, or liniments, as this may lead to adverse effects. Additionally, the product should not be applied to irritated skin.

Patients are advised to stop use and consult a health professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, or if irritation occurs. Furthermore, individuals who are pregnant or breastfeeding should seek guidance from a healthcare professional before using the product.

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 in conjunction with this medication.

Packaging & NDC

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

Packaging configurations for Raw Ice.
Details

Pediatric Use

Pediatric patients aged 6 years and older may use the gel by shaking well, cleaning the skin, and applying a liberal amount directly to the affected area until absorbed. This application may be repeated as necessary, not exceeding four times daily, and can be applied before or after activity.

For children under 6 years of age, it is advised to consult a healthcare professional prior to 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 lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. 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 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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any presenting symptoms. Supportive care may be necessary, and specific treatment protocols should be followed based on the substance and the severity of the overdosage.

In all cases, the involvement of poison control and adherence to established medical guidelines is recommended to ensure the best possible care for the patient.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

Patients should be informed not to use this product in conjunction with heating pads or other topical ointments, creams, sprays, or liniments. It is important to emphasize that the product should not be applied to irritated skin and that hands should be washed thoroughly after each application.

Healthcare providers should counsel patients to discontinue use and consult a health professional if their 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, patients who are pregnant or breastfeeding should be advised to consult a healthcare professional before using the product. It is recommended that the product be stored at room temperature.

When using this product, patients should be instructed to use it only as directed. They should avoid contact with the eyes and mucous membranes, and the product should not be applied to open wounds or damaged skin. Patients should also be cautioned against tightly bandaging the area where the product is applied.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness.

Due to its flammable nature, the product must be kept away from open flames and extreme heat sources to prevent any hazardous situations. Additionally, it is crucial to keep the product out of reach of children to ensure safety.

Healthcare professionals are advised to wash their hands thoroughly after each application to maintain hygiene. Furthermore, the product should be discarded after opening to ensure proper handling and safety.

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, it is advised to consult a healthcare professional prior to use.

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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Raw Ice, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.