Dermedial Anti-Ouch

Description

Saje® Natural Wellness Rescue Me - Nature's First Aid Kit is formulated with Dermedial Anti-Ouch+ and is presented as a Bump & Bruise Balm, classified as a topical analgesic. The product has a net weight of 0.47 oz (13.5 g).

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 not to exceed three administrations per day. 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 intervals are appropriately spaced throughout the day to maintain therapeutic effectiveness while minimizing the risk of adverse effects.

Contraindications

Use is contraindicated in patients with a known allergy to plants of the Asteraceae/Compositae/Daisy family due to the risk of allergic reactions.

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

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center without delay.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring of the patient's condition is essential to ensure appropriate management and intervention as needed.

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 discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are essential to ensure patient safety and effective management of their condition.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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.

Healthcare professionals should advise caregivers to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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 no specific data available regarding 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

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided in the current data.

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 details regarding overdosage for this medication (SPL code 34088-5), it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, healthcare providers should initiate appropriate supportive measures. This may include monitoring the patient's vital signs and providing symptomatic treatment as necessary. It is advisable to contact a poison control center or seek expert consultation for guidance tailored to the specific circumstances of the overdose.

Potential Symptoms While specific symptoms associated with overdosage are not detailed, healthcare professionals should be aware that symptoms can vary widely depending on the substance involved. Common manifestations of overdosage may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

Management Procedures Management of overdosage should be guided by the clinical presentation of the patient. Supportive care is paramount, and interventions may include the administration of activated charcoal if the patient presents within a suitable timeframe and is not at risk of aspiration. In severe cases, advanced interventions such as airway management or intravenous fluids may be required.

Healthcare professionals are encouraged to refer to established clinical guidelines and protocols for the management of overdosage to ensure optimal patient care.

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 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 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 advise patients against tightly bandaging the area where the product is applied to ensure proper healing and minimize the risk of 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.

Storage should be conducted in a controlled environment, ensuring that the temperature remains within the specified range. Containers must be kept sealed and protected from light and moisture to prevent degradation.

Special handling requirements include adherence to recycling protocols; healthcare professionals are encouraged to recycle packaging materials whenever possible to support environmental sustainability.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of up to three times daily for adults and children aged 12 years and older. There are no additional details available regarding laboratory tests, abuse information, patient counseling, 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)