Active Hydrogen Professional Gel

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is debossed with "A" on one side and "1" on the other side. Each tablet contains 1 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and color additives.

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 final 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 healthcare professional before use.

Contraindications

Use is contraindicated in the following situations:

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Discontinue use and consult a physician 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 or using it in conjunction with heating pads or medicated patches. Contact with the eyes and mucous membranes should be avoided, and the product must not be applied to open wounds or to skin that is damaged, broken, or irritated. Users may experience a slight burning sensation upon application, which is expected to dissipate shortly thereafter.

In terms of general precautions, individuals who are pregnant or breastfeeding should consult a healthcare professional prior to use. It is essential to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than seven days or resolve only to recur within a few days.

In cases of ingestion, it is critical to obtain emergency medical help or contact a Poison Control Center without delay.

Side Effects

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

A slight burning sensation may occur upon application; however, this effect is typically transient and resolves shortly after application.

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. Additionally, if symptoms clear up and then recur within a few days, medical advice should be sought.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Active Hydrogen Professional Gel (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 prior to use. This precaution is essential to ensure safety and appropriateness of treatment in this age group.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, 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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

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 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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in vital signs, neurological changes, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may include intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

3. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific management strategies tailored to the substance involved.

Healthcare professionals should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 consult a health professional if they are pregnant or breastfeeding before using the medication. It is important for patients to understand the potential risks and benefits associated with the use of the medication during these periods.

Providers should also emphasize the necessity of keeping the medication out of reach of children to prevent accidental ingestion. Patients should be informed about the importance of safeguarding medications and the potential dangers they pose to young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring patient safety and prompt action in case of accidental ingestion.

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 protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)