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Signature Care Cold and Hot

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Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
October 24, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Cream
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 2021
Label revision date
October 24, 2025
Manufacturer
Safeway Inc.
Registration number
M017
NDC root
21130-861
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Drug Overview

I'm sorry, but it seems that the information provided does not include any specific details about the drug's name, general description, or its mechanism of action. Without these key facts, I cannot create a summary that accurately describes what the drug is and what it is used for. If you have more information or a different set of details, please share, and I'll be happy to help!

Uses

You can use this medication as directed to help relieve pain in specific areas of your body. It is suitable for adults and children aged 12 years and older. To use it, apply a generous amount to the affected area and gently massage it into your skin until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times a day.

If you have a child under 12 years of age, it's important to consult a doctor before using this medication. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how often to take it, or how to apply it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

It's important to use this product safely. You should avoid applying it to any wounds or damaged skin, as this can lead to irritation or other complications. Additionally, do not use it in combination with a heating pad, as this may increase the risk of adverse effects. By following these guidelines, you can help ensure a safer experience with the product.

Side Effects

If you have a history of allergic reactions to aspirin or salicylates, it's important to consult your doctor before using this medication. Be aware of certain signs that may require you to stop using the product and seek medical advice. These include if your condition worsens or if symptoms last longer than 7 days, if symptoms improve and then return within a few days, if you experience excessive skin irritation, or if you notice redness on your skin.

Warnings and Precautions

This product is for external use only. If you have a history of allergic reactions to aspirin or salicylates, please consult your doctor before using it.

If you accidentally swallow the product, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. You should stop using the product and call your doctor if your condition worsens, if symptoms last longer than 7 days, if symptoms improve and then return within a few days, if you experience excessive skin irritation, or if you notice any redness on your skin.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 expert 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 understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 12 years old, it's important to consult with a doctor before using this product. For children aged 12 and older, you can apply the product generously to the affected area. Make sure to massage it into the skin until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times a day. Always follow these guidelines to ensure safe and effective use 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20-25°C (68-77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area. For adults and children aged 12 and older, generously massage it into the skin until fully absorbed, and you can repeat this process up to four times a day as needed. If the patient is under 12 years old, it's important to consult a doctor before use.

FAQ

How should I use this medication?

Use only as directed. For adults and children 12 years and older, apply generously to the affected area and massage until thoroughly absorbed. You can repeat this up to 4 times daily.

What should I do if I am under 12 years old?

If you are under 12 years of age, you should ask a doctor before using this medication.

Are there any contraindications for this medication?

There are no contraindications listed for this medication.

What should I avoid while using this medication?

Do not use this medication on wounds or damaged skin, and do not use it with a heating pad.

What should I do if I experience skin irritation?

Stop use and ask a doctor if excessive skin irritation or redness occurs.

What should I do if I swallow this medication?

If swallowed, get medical help or contact a Poison Control Center immediately.

Can I use this medication if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

What is the storage requirement for this medication?

Store at room temperature between 20-25°C (68-77°F).

Is there an allergy alert for this medication?

Yes, if you are prone to allergic reactions from aspirin or salicylates, consult a doctor before use.

Packaging Info

Below are the non-prescription pack sizes of Signature Care Cold and Hot (menthol, and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Signature Care Cold and Hot.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the topical treatment of localized pain in adults and children aged 12 years and older. It should be applied generously to the affected area and massaged into the skin until thoroughly absorbed. The application may be repeated as necessary, but should not exceed four times daily.

For children under 12 years of age, it is advised to consult a doctor prior to use.

This drug should be used only as directed. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to excessive heat and increase the risk of adverse effects.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a known allergy to aspirin or salicylates, as this may increase the risk of an allergic reaction.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; excessive skin irritation develops; or if there is any redness of the skin. These precautions are essential to ensure patient safety and effective management of their condition.

Side Effects

Patients should be aware of the potential for allergic reactions, particularly those who have a history of sensitivity to aspirin or salicylates. It is advised that individuals consult a healthcare professional prior to use if they are prone to such reactions.

In clinical practice, patients are instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms initially improve but then recur within a few days; excessive skin irritation develops; or if there is noticeable redness of the skin. These guidelines are essential for ensuring patient safety and effective management of adverse reactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Signature Care Cold and Hot (menthol, and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Signature Care Cold and Hot.
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 involves generously applying the product to the affected area and massaging it into the skin until fully absorbed. This process may be repeated as necessary, but should not exceed four applications per day.

Geriatric Use

There is no specific information available 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 health needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health 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 administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or specific treatments should be administered as indicated. Continuous monitoring of the patient’s condition is crucial, and healthcare providers should be prepared to manage complications that may arise during the course of treatment.

In all cases of suspected overdose, it is advisable to contact a poison control center or consult relevant clinical guidelines for further management recommendations.

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 these contexts.

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 to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important for patients to monitor their condition and to stop using the product and consult a doctor if their symptoms worsen or persist for more than 7 days. Additionally, patients should be informed to discontinue use and seek medical advice if symptoms resolve and then recur within a few days.

Patients should also be made aware that they need to stop using the product and consult a healthcare professional if they experience excessive skin irritation or if redness of the skin is present. While using the product, patients should avoid contact with their eyes or mucous membranes, and they should not bandage the area tightly.

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 room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, it should be applied generously to the affected area and massaged into the skin until fully absorbed. This process may be repeated as necessary, but should not exceed four applications per day. For children under 12 years of age, it is advised to consult a doctor before use.

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

Drug Information (PDF)

This file contains official product information for Signature Care Cold and Hot, 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 Signature Care Cold and Hot, 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.