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Achy

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This product has been discontinued

Active ingredient
Menthol 28 g/90 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
December 15, 2016
Active ingredient
Menthol 28 g/90 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
December 15, 2016
Manufacturer
Kelada Creative Group LLC DBA SALVE
Registration number
part348
NDC root
71157-0017

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 aches and pains that you may experience from various conditions, such as tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling. It works by targeting the discomfort associated with these issues, helping you feel more comfortable and active.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions. This includes discomfort from tendonitis, backaches, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.

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

Dosage and Administration

You can use this medication for yourself or your child if they are 3 years old or older. Simply apply a generous amount to the affected area and gently massage it in. You can do this up to four times a day.

If your child is under 3 years old, it’s important to consult with a doctor before using this medication to ensure it’s safe for them. Always follow these guidelines to help manage the condition effectively.

What to Avoid

It's important to keep this product out of reach of children to prevent accidental ingestion. If a child swallows it, seek medical help immediately or contact the Poison Control Center at 1-800-222-1222.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always use it responsibly and as directed.

Side Effects

When using this product, it's important to apply it only as directed and for external use only. Be careful to avoid contact with your eyes and mucous membranes, and do not apply it to any wounds or broken skin.

If you experience excessive skin irritation or if your condition worsens, you should stop using the product and consult a doctor for further advice.

Warnings and Precautions

This product is intended for external use only, so please do not use it in any other way. When applying, be careful to avoid contact with your eyes and mucous membranes, and do not apply it to any wounds or broken skin.

If you experience excessive skin irritation or if your condition worsens, stop using the product and consult your doctor. Additionally, if the product is swallowed, seek emergency medical help immediately or contact the Poison Control Center at 1-800-222-1222.

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 unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the best options for your health and the health of your baby. Always prioritize open communication with your doctor about any concerns you may have.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, and the safety of this product during lactation (the period of breastfeeding) has not been established. Therefore, exercising caution is advised when considering its use while nursing. Your healthcare provider can help you weigh the benefits and risks to ensure the best outcome for you and your baby.

Pediatric Use

If you have a child who is 3 years old or older, you can apply the product to the affected area up to four times a day. Just make sure to massage it in gently. However, if your child is under 3 years old, it's important to consult with a doctor before using this product to ensure it's safe for them. Always prioritize your child's health and follow these guidelines for their well-being.

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 for personalized advice. They can help determine the best approach to using this medication safely and effectively, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 related to 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 listed 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 tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, away from direct sunlight and moisture. It's important to keep it out of reach of children to prevent accidental ingestion. If the product is swallowed, seek medical assistance or contact the Poison Control Center immediately for guidance.

By following these simple storage and handling tips, you can help ensure that the product remains safe for use.

Additional Information

You should use this product only on the skin (topically) and apply it to the affected area by gently massaging it in, up to four times a day for adults and children aged 3 years and older. If your child is under 3 years old, consult a doctor before use. Remember, this product is for external use only, so avoid contact with your eyes and mucous membranes, and do not apply it to wounds or broken skin.

If you experience excessive skin irritation or if your condition worsens, stop using the product and consult a doctor. Always keep it out of reach of children, and if swallowed, seek medical help immediately or contact the Poison Control Center at 1-800-222-1222.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.

How should adults and children over 3 years use this product?

Adults and children 3 years of age and older should liberally massage the affected area not more than 4 times daily.

What should I do if I have a child under 3 years?

If using on a child under 3 years of age, you should ask a doctor before using.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take when using this product?

This product is for external use only. Avoid contact with eyes and mucous membranes, and do not apply to wounds or broken skin.

What should I do if I experience excessive skin irritation?

You should stop using the product and ask a doctor if excessive skin irritation develops or if your condition worsens.

What should I do if the product is swallowed?

If swallowed, get medical help or contact Poison Control Center right away at 1-800-222-1222.

Is this drug safe to use during pregnancy or while breastfeeding?

There is no specific information regarding safety during pregnancy. Nursing mothers should consult a doctor before using, as there is a potential for excretion in breast milk.

How should I store this product?

Store the product at room temperature and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Achy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product associated with SPL code 34089-3 does not have any relevant details available in the provided text. Further information regarding its chemical composition, molecular weight, dosage form, or appearance is not specified.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.

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

Dosage and Administration

Adults and children aged 3 years and older should apply the product liberally to the affected area, not exceeding four applications per day. For children under 3 years of age, it is advised to consult a physician prior to use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

For external use only. This product should not be used other than as directed. When applying this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, it should not be applied to wounds or broken skin to prevent adverse reactions.

Healthcare professionals should advise patients to discontinue use and seek medical attention if excessive skin irritation develops or if the condition worsens during treatment.

In the event of accidental ingestion, immediate medical assistance is required. Patients should be instructed to contact a healthcare provider or the Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients should be aware that this product is for external use only and should not be used other than as directed. It is important to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or broken skin.

In the event of excessive skin irritation or if the condition worsens, patients are advised to stop use and consult a healthcare professional. These precautions are essential to ensure the safe and effective use of the product.

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 Achy (menthol cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Achy.
Details

Pediatric Use

Pediatric patients aged 3 years and older may apply the medication to the affected area, massaging it in liberally, up to four times daily. For children under 3 years of age, it is advised to consult a physician prior to use.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management 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 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 the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help immediately or contact the Poison Control Center at 1-800-222-1222 for assistance. This information is crucial for ensuring patient safety and prompt action in case of an emergency.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, away from direct sunlight and moisture. To ensure safety, it is imperative to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Additional Clinical Information

The product is intended for topical administration, with recommended use for adults and children aged 3 years and older to apply liberally to the affected area up to four times daily. For children under 3 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients that the product is for external use only and must not be used other than as directed. Patients should avoid contact with eyes and mucous membranes, and the product should not be applied to wounds or broken skin. If excessive skin irritation occurs or if the condition worsens, patients are advised to discontinue use and consult a doctor. Additionally, the product should be kept out of reach of children, and in the event of ingestion, medical assistance should be sought immediately or the Poison Control Center contacted at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Achy, 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 Achy, 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.