Topical Analgesic

Description

The compound has a molecular weight of 141 g.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritation.

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

Dosage and Administration

Adults and children 16 years of age and older should wash the affected area with mild soap and warm water, ensuring it is rinsed thoroughly. The medication should then be applied to the affected area no more than 3 to 4 times daily. It is important to avoid bandaging tightly or applying the medication to wounds or damaged skin.

For children under 16 years of age, it is recommended to consult a doctor prior to use.

Contraindications

Use is contraindicated in children under 16 years of age unless directed by a physician. This precaution is necessary to ensure safety and efficacy in this age group.

Warnings and Precautions

For external use only; this product is flammable and should be kept away from fire or flames. Healthcare professionals should advise patients to avoid contact with the eyes and to refrain from applying the product over large areas of the body. It is important to avoid tight bandaging of the area where the product is applied.

Patients should be instructed to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Special consideration should be given to pregnant or breastfeeding individuals, who are advised to seek guidance from a healthcare professional prior to use.

This product must be kept 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.

While using this product, it is crucial to keep it away from the eyes, ears, and mouth. Should contact with the eyes occur, the affected individual should rinse their eyes thoroughly with water. Additionally, if irritation or a rash develops, the patient should stop using the product and consult a healthcare provider, as these symptoms may indicate a serious condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and is flammable; therefore, it should be kept away from fire or flames. Patients are advised to avoid contact with the eyes and to refrain from bandaging the area tightly. Additionally, it is recommended not to apply the product over large areas of the body.

In clinical practice, patients are instructed to 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. Special considerations should be taken for pregnant or breastfeeding individuals, who should seek advice from a healthcare professional prior to use.

It is crucial to keep this product out of the reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Topical Analgesic (dermaline arnica menthol gel). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 16 years of age should not use this medication unless advised by a physician. It is essential for healthcare professionals to consult with a doctor before prescribing this treatment to children in this age group.

Geriatric Use

Elderly patients should be advised that this medication is not indicated for use in children under 16 years of age unless specifically recommended by a physician. For adults and geriatric patients aged 16 years and older, the recommended application frequency is to the affected area no more than 3 to 4 times daily.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, ensuring that the treatment plan is appropriate for their specific health status and any concurrent medications. It is essential to monitor for any adverse effects or complications that may arise due to the unique physiological changes associated with aging.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 specific information 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 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 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 available information.

Overdosage

In the event of accidental ingestion, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In all cases of suspected overdosage, it is vital to gather as much information as possible regarding the substance, the amount ingested, and the time of ingestion to facilitate appropriate medical intervention.

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 this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

It is important to inform patients that this product should not be used on children under 16 years of age unless directed by a physician. Patients should be instructed 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 recur within a few days.

For patients who are pregnant or breastfeeding, it is essential to recommend that they consult a health professional before using this product.

Patients should also be cautioned to avoid contact with the eyes, ears, and mouth while using the product. In the case of accidental contact with the eyes, they should rinse thoroughly with water. Additionally, patients should be advised to discontinue use and seek medical advice if they experience irritation or a rash, as these may indicate a serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15-30°C (59-86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

Adults and children aged 16 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Patients should discontinue use and seek medical advice if they experience irritation or rash, as these may indicate a serious condition. Additionally, if the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients should also consult a doctor.

Drug Information (PDF)

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

View product document (PDF)