Dg Health

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for first aid to help prevent bacterial contamination or skin infection. It provides temporary relief of pain and itching associated with minor cuts, scrapes, burns, sunburn, and skin irritations.

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

Dosage and Administration

For adults and children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product should be sprayed onto the area 1 to 3 times daily. After application, the area may be covered with a sterile bandage, ensuring that the product is allowed to dry first.

For children under 2 years of age, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Application in or near the eyes is prohibited due to the potential for irritation or damage to ocular tissues. Additionally, the product should not be applied over large areas of the body or in large quantities, as this may increase the risk of systemic absorption and adverse effects. Furthermore, application over raw surfaces or blistered areas is contraindicated to prevent exacerbation of irritation or potential infection.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if they have deep or puncture wounds, animal bites, or serious burns, as these conditions may require specialized treatment.

During the application of this product, it is imperative to avoid contact with the eyes. Additionally, the product should not be applied over large areas of the body or in excessive quantities. It is also contraindicated to apply the product over raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects.

Patients should be instructed to discontinue use and seek medical advice if their 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, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important to consult a healthcare professional prior to use if there are any deep or puncture wounds, animal bites, or serious burns present.

While using this product, patients are advised against applying it in or near the eyes, over large areas of the body, or in large quantities. Additionally, it should not be applied over raw surfaces or blistered areas.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health (benzalkonium cl, lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product may be sprayed on the area 1 to 3 times daily. After application, the area may be covered with a sterile bandage, ensuring it is allowed to dry first.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any concerns with patients and consider alternative therapies where appropriate.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. However, it is always advisable to monitor breastfed infants for any potential effects when the mother is taking medication.

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 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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 question.

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 to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients should also stop use and seek medical advice.

It is important to inform patients that this product should not be used in or near the eyes. They should be cautioned against applying the product over large areas of the body or in large quantities. Furthermore, patients should avoid applying the product over raw surfaces or blistered areas.

Healthcare providers should recommend that patients consult a doctor before using this product if they have deep or puncture wounds, animal bites, or serious burns. This ensures that patients receive appropriate guidance tailored to their specific medical conditions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)