Ease Your Pain

Description

Astura Ease Your Pain is a pharmaceutical product packaged in a 3 oz container. The effective date of the insert is January 21, 2019.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is 3 to 4 times daily to the affected area. It is important to ensure that the application does not exceed this frequency to maintain safety and efficacy.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage the area or use it in conjunction with heating pads, other ointments, creams, sprays, or liniments, as this may lead to increased absorption and potential side effects.

Warnings and Precautions

Use of this product should be strictly in accordance with the provided directions. It is intended for external use only and must be kept away from excessive heat or open flame to prevent any hazardous situations.

When utilizing this product, it is crucial to avoid contact with the eyes and mucous membranes. Application to wounds or damaged skin is contraindicated. Additionally, the product should not be bandaged or used in conjunction with heating pads, other ointments, creams, sprays, or liniments, as this may lead to adverse effects.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days.

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 the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product. It is essential to use the product only as directed and for external use only, avoiding contact with excessive heat or flame.

Participants are advised to avoid contact with eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and it is important not to bandage the area or use it in conjunction with heating pads, other ointments, creams, sprays, or liniments.

Patients should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using the product.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center is advised.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

It is important to keep the medication 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.

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

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, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health 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 text 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 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 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, it is imperative to keep the medication out of reach of children. Accidental ingestion by a child necessitates immediate medical intervention. Healthcare professionals should advise caregivers to seek medical assistance or contact the Poison Control Center without delay.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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

Serious side effects have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated contact number provided above.

Patient Counseling

Patients should be advised to keep this product out of reach of children. In the event of accidental ingestion, they should seek medical help or contact the Poison Control Center immediately.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

While using this product, patients must be cautioned to avoid contact with the eyes and mucous membranes. They should not apply the product to wounds or damaged skin. Additionally, patients should be informed not to bandage the area or use it in conjunction with heating pads, other ointments, creams, sprays, or liniments.

Storage and Handling

The product is supplied in a tamper-evident container to ensure user safety; it should only be used if the safety seal is intact. It is essential to store the product in a cool, dry place, away from direct sunlight. Additionally, it must be kept away from excessive heat or flame to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only and should be kept away from excessive heat or flame. Patients must avoid contact with eyes and mucous membranes, and should not apply it to wounds or damaged skin. Bandaging or using the product in conjunction with heating pads, other ointments, creams, sprays, or liniments is not recommended. Patients should discontinue use and consult a doctor if the condition worsens, symptoms persist beyond 7 days, or if symptoms clear up and recur within a few days. Pregnant or breastfeeding patients should seek advice from a health professional before use. Additionally, the product should be kept out of reach of children, and in the event of accidental ingestion, medical help or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)