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Cold and Heat Pain Relieving Cream

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This product has been discontinued

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 2018
Label revision date
August 9, 2018
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 2018
Label revision date
August 9, 2018
Manufacturer
SOTAC PHARMACEUTICALS PRIVATE LIMITED
Registration number
part348
NDC root
72351-010
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

This medication is designed to temporarily relieve minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps. It works by targeting the discomfort you may experience from these common ailments, helping you feel more comfortable and active.

Uses

If you're dealing with minor pain, this medication can help provide temporary relief. It's effective for various types of discomfort, including pain from arthritis, simple backaches, muscle strains, sprains, bruises, and cramps. Whether you're recovering from an injury or just experiencing everyday aches, this medication can support your comfort.

Rest assured, there are no known 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

If you are an adult or a child over 12 years old, you should apply the medication generously to the area that is causing you pain. After applying, gently massage it into your skin until it is fully absorbed. You can repeat this process as needed, but make sure not to apply it more than four times in a single day.

For children who are 12 years old or younger, it’s important to consult a doctor before using this medication. Always follow their guidance to ensure safety and effectiveness.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not bandage the area tightly or use a heating pad while using this product. Additionally, avoid applying it to any wounds or areas of skin that are damaged, broken, or irritated. Make sure to keep it away from your eyes and mucous membranes to prevent irritation.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

If you have a history of allergic reactions to aspirin or salicylates, it's important to talk to your doctor before using this medication.

You should stop using the product and consult your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms last longer than 7 days or return after clearing up.

Warnings and Precautions

This product is for external use only, so please follow the instructions carefully. If you have a history of allergic reactions to aspirin or salicylates, it's important to consult your doctor before using this product. Avoid applying it to wounds, broken skin, or irritated areas, and do not use it with a heating pad or bandage it tightly. Keep it away from your eyes and mucous membranes.

If your condition worsens, if you notice redness or irritation, or if your symptoms last longer than 7 days or return after clearing up, stop using the product and contact your doctor. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention. Always err on the side of caution and reach out for help if you are unsure. Your safety is the top priority, so don’t hesitate to get the assistance you need.

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

Pediatric Use

If you are considering this medication for a child who is 12 years old or younger, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize professional guidance when it comes to the health of your little ones.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to 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 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 how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to talk to your healthcare provider if you have a history of allergic reactions to aspirin or salicylates (a group of drugs that includes aspirin). They can help determine if this medication is safe for you.

While there are no specific interactions with other drugs or lab tests noted, discussing all your current medications and any upcoming tests with your doctor is always a good practice. This ensures your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature and keep it protected from light. It's important to keep the product out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, remember to discard it after use to maintain safety and hygiene. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, gently massaging it into the skin until fully absorbed. For adults and children over 12 years, you can repeat this process as needed, but do not exceed four applications in a day. If the user is a child under 12, consult a doctor before use.

It's important to be aware of a few safety precautions. If you have a history of allergic reactions to aspirin or salicylates, talk to your doctor before using this product. Additionally, if you are pregnant or breastfeeding, consult a healthcare professional. Always keep the medication out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What minor pains does this drug relieve?

This drug temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

How should I use this drug if I am an adult or a child over 12?

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 a child 12 years or younger?

If you are a child 12 years or younger, you should ask a doctor before use.

Are there any specific instructions for using this drug?

Use only as directed, avoid bandaging tightly, and do not apply to wounds or irritated skin. Also, avoid contact with eyes or mucous membranes.

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

Stop use and ask a doctor if your condition worsens, redness is present, irritation develops, or symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy or breastfeeding?

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

What should I do if I accidentally swallow this drug?

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

Are there any allergy alerts associated with this drug?

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

How should I store this drug?

Store at room temperature, protect from light, and keep out of reach of children. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Cold and Heat Pain Relieving Cream (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold and Heat Pain Relieving Cream.
Details

Drug Information (PDF)

This file contains official product information for Cold and Heat Pain Relieving Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "B" on the other. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and iron oxides (red and yellow).

Uses and Indications

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

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage is to apply the product generously to the affected area. The application should be followed by massaging the product into the painful area until it is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

The product should not be used in the following situations:

Tight bandaging or the use of heating pads in conjunction with the product is contraindicated, as this may lead to adverse effects. Application to wounds or damaged, broken, or irritated skin is also contraindicated due to the potential for irritation or exacerbation of the condition. Additionally, contact with eyes or mucous membranes must be avoided to prevent serious irritation or injury.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to refer to the inside label for complete drug facts.

Allergy Alert: Patients with a history of allergic reactions to aspirin or salicylates are advised to consult a healthcare provider prior to use.

General Precautions: The product should be used strictly as directed. It is important to avoid bandaging the area tightly or using it in conjunction with a heating pad. Contact with the eyes or mucous membranes must be avoided, and the product should not be applied to wounds or any damaged, broken, or irritated skin.

Stop Use and Consult a Doctor If: The patient's condition worsens, if redness occurs, if irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

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

Side Effects

Patients should be aware of the potential for adverse reactions associated with the use of this medication.

In terms of serious adverse reactions, individuals who have a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use. This precaution is particularly important for those with a history of allergic reactions, as it may lead to severe outcomes.

Common adverse reactions may include worsening of the condition being treated, the presence of redness, or the development of irritation. Patients are advised to discontinue use and seek medical advice if any of these symptoms occur. Additionally, if symptoms persist for more than seven days or if they resolve and then recur within a few days, it is recommended that patients consult a healthcare provider for further evaluation.

Monitoring for these reactions is essential to ensure patient safety and effective management of any adverse effects that may arise during treatment.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use, as there is a potential for allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Heat Pain Relieving Cream (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold and Heat Pain Relieving Cream.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on the excretion of this drug in human 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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing 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 should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

When using this product, patients must be reminded to use it only as directed. They should not bandage the area tightly or use it in conjunction with a heating pad. It is also important to advise patients to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or to damaged, broken, or irritated skin.

Storage and Handling

The product is supplied in packaging that ensures its integrity and safety. It should be stored at room temperature, away from direct light exposure to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years should apply the product generously to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of four times daily. For children aged 12 years or younger, it is advised to consult a doctor before use.

Clinicians should counsel patients on important safety information. Individuals with a history of allergic reactions to aspirin or salicylates should seek medical advice prior to use. Pregnant or breastfeeding patients are also encouraged to consult a healthcare professional. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

Drug Information (PDF)

This file contains official product information for Cold and Heat Pain Relieving Cream, 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 Cold and Heat Pain Relieving Cream, 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.