Active Hydrogen Professional

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 the reduction and cessation of the inflammatory process, alleviation of pain, and reduction of swelling. It is also indicated to expedite the recovery process following injuries and to neutralize the excretion of lactic acid in the muscles.

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

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the product should be applied directly to the affected area. The application should be followed by gentle massage into the skin until the product is thoroughly absorbed. This process may be repeated several times, specifically 4 to 5 times, as needed. After the application, it is recommended to wipe the area with a wet hand to alleviate any residual tension. The application should be performed a minimum of three times per day to ensure optimal results.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid bandaging the area after application, as well as refraining from using heating pads or medicated patches in conjunction with this treatment. Contact with the eyes and mucous membranes should be avoided to prevent irritation. Additionally, the product should not be applied to open wounds or any skin that is damaged, broken, or irritated. Users may experience a slight burning sensation upon application, which is typically transient.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of the condition, the presence of redness, development of irritation, or if symptoms persist beyond seven days. Patients should also be instructed to seek medical advice if symptoms resolve and then recur within a few days. Regular monitoring of the patient's response to treatment is recommended to ensure safety and efficacy.

Side Effects

Patients should be aware that the product is for external use only and must be used strictly as directed. It is important to avoid bandaging the area or using it in conjunction with heating pads or medicated patches. Contact with the eyes and mucous membranes should be avoided, and the product should not be applied to open wounds or to damaged, broken, or irritated skin.

In clinical use, a slight burning sensation may occur upon application, although this typically resolves quickly. Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 should be aware that there are no specific warnings, precautions, or dosage modifications regarding the use of this product during pregnancy. The product is intended for external use only, and no pregnancy-related information has been provided in the labeling. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

The safety of this product during lactation has not been established. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to nursing mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult their healthcare provider if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days. It is important for patients to be aware of these signs and to seek guidance promptly to ensure their safety and well-being.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure, to ensure optimal stability. Freezing the product is not permitted, as it may compromise its effectiveness. Once opened, the product should be discarded after use to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically, requiring patients to apply a thin layer to the affected area and massage it into the skin until fully absorbed. This process should be repeated several times, specifically 4 to 5 times, and followed by wiping the area with a wet hand to alleviate any tension. Patients are advised to repeat this application at least three times per day to achieve optimal results.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)