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Rite Aid Hot and Cold Roll on

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Active ingredient
Menthol 16 g/100 g
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
December 15, 2024
Active ingredient
Menthol 16 g/100 g
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
December 15, 2024
Manufacturer
Rite Aid
Registration number
M017
NDC root
11822-1015

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Drug Overview

This medication is designed to provide temporary relief from minor pain associated with conditions such as arthritis, simple backaches, muscle strains, sprains, bruises, and cramps. It can help ease discomfort and improve your ability to carry out daily activities when you're experiencing these types of pain.

If you're dealing with any of these minor pain issues, this medication may be a helpful option to consider for short-term relief. Always consult with a healthcare professional to ensure it's appropriate for your specific situation.

Uses

You can use this medication for the temporary relief of minor pain caused by various conditions. This includes discomfort related to arthritis, simple backaches, muscle strains, sprains, bruises, and cramps. If you're experiencing any of these types of pain, this medication may help alleviate your symptoms and improve your comfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

Before using the product, make sure to clean the affected area thoroughly. This helps ensure that the medication works effectively. If you are an adult or a child aged 12 years and older, you can apply the product to the affected area up to 3 to 4 times a day.

For children under 12 years old, it’s important to consult a doctor before use to ensure safety and proper dosage. Always follow these guidelines to achieve the best results from your treatment.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. This is crucial for your safety, as prompt action can help prevent potential harm.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this product. Always follow the guidance provided to ensure safe usage.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid contact with your eyes and refrain from applying it to wounds or damaged skin. Additionally, do not bandage the area tightly. If your condition worsens, symptoms persist for more than 7 days, or if you notice any redness or irritation, stop using the product and consult a doctor.

Please remember that this product is flammable, so keep it away from fire or flames, and it is intended for external use only.

Warnings and Precautions

It's important to use this product safely. Remember that it is flammable, so keep it away from fire or flames. This product is for external use only, so avoid getting it in your eyes, applying it to wounds or damaged skin, and do not bandage the area tightly. If your condition worsens, if symptoms last more than 7 days, or if they clear and then come back within a few days, stop using the product and consult your doctor. Additionally, if you notice any redness or irritation, you should also stop use and seek medical advice.

In case the product is swallowed, seek emergency medical help immediately or contact a Poison Control Center. Always prioritize your safety and well-being when using any medication.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

Pregnancy Use

There is currently no information available about the use of RITE AID HOT AND COLD ROLL ON (which contains 16% menthol) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, you can apply it to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure your safety while using this product, remember that it is flammable, so keep it away from any fire or flame. This product is intended for external use only, so please do not apply it to any internal areas. Before using it, make sure to clean the affected area thoroughly to promote effective application.

For storage, keep the product at room temperature to maintain its effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this product only on the skin (topically) and apply it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the user is under 12 years old, consult a doctor first. Remember, this product is for external use only, so keep it away from your eyes and do not apply it to wounds or damaged skin. Avoid tightly bandaging the area after application.

Before applying, make sure to clean the affected area. If your condition worsens, lasts more than 7 days, or comes back after clearing, stop using the product and consult a doctor. Additionally, if you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately.

FAQ

What is this drug used for?

This drug is used for the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

How should I apply this product?

Clean the affected area before applying the product. Adults and children 12 years and older should apply it to the affected area no more than 3 to 4 times daily.

What should I do if I swallow this product?

If the product is swallowed, get medical help or contact a Poison Control Center right away.

Are there any warnings I should be aware of?

Yes, the product is flammable, for external use only, and should be kept out of the eyes. Do not apply to wounds or damaged skin, and do not bandage tightly.

What should I do if my condition worsens?

Stop using the product and ask a doctor if your condition worsens, if symptoms last more than 7 days, or if redness or irritation develops.

Can children under 12 use this product?

Children under 12 years old should ask a doctor before use.

Is there any information regarding use during pregnancy or lactation?

There are no specific warnings or considerations mentioned regarding use during pregnancy or lactation.

Packaging Info

Below are the non-prescription pack sizes of Rite Aid Hot and Cold Roll on (menthol 16%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rite Aid Hot and Cold Roll on.
Details

Drug Information (PDF)

This file contains official product information for Rite Aid Hot and Cold Roll on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is a combination of acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride. Each tablet contains 500 mg of acetaminophen, 25 mg of diphenhydramine hydrochloride, and 10 mg of phenylephrine hydrochloride. Inactive ingredients include anhydrous lactose, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, and talc. The tablets are round, biconvex, and coated with a light blue film.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

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

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 12 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

The product is flammable; therefore, it must be kept away from fire or flame. It is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, it is important to avoid tight bandaging of the area where the product is applied.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if any redness or irritation develops.

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

Healthcare professionals are encouraged to monitor patients for any adverse reactions and to provide guidance on the appropriate use of the product to ensure safety and efficacy.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is flammable and should be kept away from fire or flame. The product is intended for external use only. When using this product, patients should avoid contact with the eyes, refrain from applying it to wounds or damaged skin, and should not bandage the area tightly.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear and then recur within a few days, patients are advised to stop use and consult a doctor. Additionally, if any redness or irritation develops, it is important to discontinue use and seek medical advice.

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 Rite Aid Hot and Cold Roll on (menthol 16%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rite Aid Hot and Cold Roll on.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of RITE AID HOT AND COLD ROLL ON (menthol 16% liquid) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant patients, as the potential risks and effects on fetal outcomes are not established. It is advisable to weigh the benefits against any unknown risks when recommending this product to women of childbearing potential.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific contraindications. However, as with any medication, it is advisable to monitor breastfed infants for any potential adverse effects.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be warranted in these patients to ensure safety and efficacy.

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 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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients that if the product is swallowed, it is imperative to seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring patient safety and prompt intervention in case of accidental ingestion.

Storage and Handling

The product is classified as flammable; therefore, it must be kept away from fire or flame. It is intended for external use only, and users are advised to clean the affected area prior to application.

Storage conditions require the product to be maintained at room temperature to ensure its efficacy and safety.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients that the product is for external use only. It is important to avoid contact with the eyes, refrain from applying it to wounds or damaged skin, and not to bandage the area tightly. Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist beyond 7 days, if symptoms clear and then recur within a few days, or if redness or irritation occurs. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary. Patients are also advised to clean the affected area before application.

Drug Information (PDF)

This file contains official product information for Rite Aid Hot and Cold Roll on, 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 Rite Aid Hot and Cold Roll on, 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

Last AI update:

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.