Dermedial Anti-Ouch

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older.

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

Dosage and Administration

The recommended dosage for the medication is to administer it no more than three times daily. It is important to note that this medication is not recommended for use in children under 12 years of age. Healthcare professionals should ensure that the dosing frequency does not exceed the specified limit to maintain safety and efficacy.

Contraindications

Use is contraindicated in individuals with a known allergy to plants of the Asteraceae/Compositae/Daisy family due to the potential for severe allergic reactions.

Additionally, the product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to complications. Contact with the eyes must be avoided to prevent irritation or injury. Furthermore, tight bandaging of the area where the product is applied is contraindicated, as it may impede circulation and lead to adverse effects.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from fire or flame to prevent any risk of ignition.

General precautions must be observed when using this product. It should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Additionally, individuals with known allergies to plants of the Asteraceae/Compositae/Daisy family should refrain from using this product to avoid potential allergic reactions.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately to ensure appropriate care is provided.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from fire or flame.

In clinical practice, patients are advised to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. These precautions are essential to ensure the safety and efficacy of the treatment.

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 Dermedial Anti-Ouch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age are not recommended to use this product. For adolescents aged 12 years and older, the recommended application is to the affected area no more than three times daily.

It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center.

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. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

There is no specific information available 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 advisable 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 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 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, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as required.

Nonclinical Toxicology

There are no teratogenic effects observed in the nonclinical studies conducted. Additionally, no non-teratogenic effects have been reported. The available data does not indicate any findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin to prevent further complications.

Patients should be informed of the potential for allergic reactions and advised not to use the product if they have a known allergy to plants in the asteraceae/compositae/daisy family. Providers should emphasize the importance of discontinuing use and consulting a doctor if the patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, healthcare providers should remind patients to avoid contact with the eyes while using the product. It is also crucial to inform patients that they should not bandage the area tightly when using the product, as this may lead to adverse effects.

Storage and Handling

The product is available in various packaging configurations, with specific NDC numbers provided for identification. It is essential to store the product under appropriate conditions to maintain its integrity and efficacy.

The recommended storage temperature range is between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). The product should be kept in its original container to protect it from light and moisture.

Healthcare professionals are encouraged to handle the product with care and to follow all applicable guidelines for safe storage and disposal. Additionally, the organization supports recycling initiatives and encourages the recycling of packaging materials where possible.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the product to the affected area no more than three times daily. Clinicians should counsel patients to consult a doctor if they are pregnant or breastfeeding before use. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)