Active Hydrogen Professional Cream

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the reduction and cessation of inflammatory processes. It effectively eliminates pain and reduces swelling associated with various conditions. Additionally, this drug is utilized to expedite the recovery process following injuries. It also neutralizes the excretion of lactic acid in the muscles, contributing to improved muscle function and comfort.

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication 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 once more, ensuring that the total number of applications is a minimum of three times per day.

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

Contraindications

Use is contraindicated in the following situations:

Pregnant or breastfeeding individuals should consult a healthcare professional before use due to potential risks to the fetus or infant.

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

Discontinue use and consult a physician if the condition worsens, if redness occurs, if irritation develops, or if symptoms persist for more than 7 days or resolve and recur within a few days.

Warnings and Precautions

For external use only. This product should 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 must be avoided, and the product should not be applied to open wounds or any damaged, broken, or irritated skin. 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.

Users are instructed to discontinue use and consult a physician if any of the following occur: the condition worsens, redness develops, irritation arises, or if symptoms persist for more than seven days or resolve and then recur within a few days.

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. It is crucial that patients use the product strictly as directed. Bandaging the area or using it in conjunction with a heating pad or medicated patch is not recommended. Additionally, contact with the 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.

Upon application, patients may experience a slight burning sensation, which typically resolves shortly after use. However, if the condition worsens, if redness or irritation develops, or if symptoms persist for more than 7 days, patients are advised to discontinue use and consult a healthcare professional. Furthermore, if symptoms clear up and then recur within a few days, it is also recommended that patients seek medical advice.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Cream (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 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 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

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 product. It is important to emphasize the necessity of keeping the product out of reach of children to prevent accidental ingestion.

In the event that the product is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. Additionally, healthcare providers should remind patients to use the product within 90 days after opening to ensure its effectiveness and safety.

Storage and Handling

The product is supplied in a configuration that allows for optimal use within 90 days after opening. It is essential to adhere to this timeframe to ensure the integrity and efficacy of the product.

Storage conditions should be carefully monitored to maintain product quality. It is recommended to store the product in a cool, dry place, away from direct sunlight and extreme temperatures. Proper container requirements must be followed to prevent contamination and degradation. Special handling needs should be observed to ensure the product remains safe and effective throughout its usage period.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin layer to the affected area for adults and children over 12 years. Patients should massage the product into the skin until fully absorbed and may repeat this process at least three times daily. For children under 12 years, consultation with a healthcare professional is advised prior to use.

Clinicians should counsel patients to seek medical advice if they are pregnant or breastfeeding. It is important to keep the product out of reach of children, and in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary. Patients are advised to use the product within 90 days of opening and to discontinue use and consult a doctor if the condition worsens, if redness or irritation occurs, or if symptoms persist beyond seven days or recur shortly after resolution.

Drug Information (PDF)

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

View product document (PDF)