Healing Hand Cream 2000mg

Description

SPL code 34089-3 identifies a topical formulation known as Healing Hand Cream, designed to moisturize and protect the skin. This cream incorporates a blend of emollients and humectants, with active ingredients including glycerin and dimethicone. The inactive ingredients comprise water, cetyl alcohol, stearyl alcohol, among others. The cream is characterized by its white to off-white color and smooth texture. It is packaged in a 4 oz (113 g) tube.

Uses and Indications

This drug is indicated for the temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is to apply the medication to the affected area one to four times daily, depending on the severity of the condition.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

The product should not be applied to wounds or irritated skin, as this may exacerbate the condition or lead to adverse effects. Additionally, contact with the eyes must be avoided to prevent irritation or injury.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is intended solely for external application and provides penetrating pain relief.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, the condition resolves but recurs within a few days, or if a rash or irritation develops.

It is crucial to emphasize general precautions to patients. The product should not be applied to open wounds or irritated skin, and care should be taken to avoid contact with the eyes to prevent adverse effects.

In the absence of specific emergency medical instructions, healthcare providers should remain vigilant and encourage patients to seek immediate medical attention if they experience any severe or unexpected reactions.

Side Effects

Patients using this product should be aware that it is intended for external use only and is designed to provide penetrating pain relief.

In clinical practice, participants are advised to stop use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if the condition resolves but recurs within a few days. Additionally, the occurrence of a rash or irritation necessitates discontinuation of use and medical consultation.

Adverse reactions reported include worsening of the condition, prolonged symptoms lasting beyond 7 days, recurrence of symptoms after initial resolution, and the development of rash or irritation. These reactions should be monitored closely, and patients are encouraged to seek medical advice if they experience any of these issues.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Healing Hand Cream 2000mg (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age and 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

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 should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no available data regarding 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance or contact a poison control center. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdosage.

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

Management of overdosage typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and act swiftly to ensure the safety and well-being of the patient experiencing an overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse.

Patients should be informed to monitor their condition closely. They should seek medical attention if their symptoms worsen, persist for more than 7 days, resolve but then recur within a few days, or if they experience any rash or irritation.

It is important to instruct patients not to apply the medication to wounds or irritated skin, and to avoid contact with the eyes to prevent potential adverse effects.

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 a temperature range of 68 to 77 degrees Fahrenheit. Care should be taken to avoid direct sunlight during storage to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Healing Hand Cream 2000mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)