Healthwise Medicated Original Body Powder 10 Oz

Description

HealthWise Medicated Original Body Powder is a topical formulation designed for use on the skin. The product is intended to provide a soothing effect and is formulated to absorb moisture. It is packaged in a convenient powder form, allowing for easy application. The effective date for this formulation is December 1, 2024.

Uses and Indications

This drug is indicated for the temporary relief of pain and itch associated with minor cuts, scrapes, sunburn, insect bites, prickly heat, rashes, minor burns, and minor skin irritation. Additionally, it is effective in drying the oozing of poison ivy, oak, and sumac.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the medication freely up to 3 or 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

For optimal results, it is essential to ensure that the skin is thoroughly dried before application. This preparation step may enhance the effectiveness of the treatment.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to keep the product out of reach of children.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, persistence or increase of redness, irritation, swelling, or pain, or if symptoms do not improve within 7 days or recur shortly after resolution.

Additionally, contact with the eyes should be avoided to prevent potential irritation or injury.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if any of the following occur: the condition worsens, redness, irritation, swelling, or pain persists or increases, or if symptoms do not improve within 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients should be aware that this product is intended for external use only. It is crucial to avoid contact with the eyes during application.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, persistence or increase of redness, irritation, swelling, or pain, or if symptoms do not improve within 7 days. Additionally, if symptoms clear up and then recur within a few days, medical advice should be sought. These recommendations are based on clinical observations and are intended to ensure patient safety and effective use of the product.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Healthwise Medicated Original Body Powder 10 Oz (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the product may be applied freely up to 3 or 4 times daily.

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, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 event of accidental ingestion, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is crucial to ensure the safety and well-being of the patient.

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

Management of overdosage should be guided by the specific clinical scenario and may include supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In all cases of suspected overdosage, it is vital to gather as much information as possible regarding the substance, amount ingested, and the time of ingestion to facilitate appropriate medical 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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 of accidental ingestion, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if their condition worsens. Additionally, they should be advised to stop using the medication and seek medical advice if they experience persistent or increasing redness, irritation, swelling, or pain. It is important to communicate that if symptoms do not improve within 7 days, or if they resolve and then recur within a few days, patients should also consult a doctor.

Furthermore, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this medication.

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 excessive heat, to ensure optimal stability and efficacy. Additionally, it is important to keep the product out of reach of children. Once opened, the product should be discarded to prevent any potential safety concerns.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of up to three or four times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Healthwise Medicated Original Body Powder 10 Oz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)