Natural 17 Herbal Splash

Description

NATURAL 17 - HERBAL SPLASH is a product formulated for topical application. The effective date of this formulation is September 15, 2023. Further details regarding its chemical composition, molecular weight, or inactive ingredients are not provided.

Uses and Indications

This drug is indicated for the temporary relief of minor pains associated with muscles and joints.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage is to spray two to three pumps onto the affected area as necessary, not exceeding three to four applications per day.

In children under 12 years of age, the use of this product is not recommended without consulting a healthcare professional.

Contraindications

The product should not be used in areas that will be exposed to heat or direct sunlight following treatment. This precaution is necessary to prevent potential adverse effects on the treated area. No other contraindications have been specified.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for application on wounds or damaged skin, and should not be used in conjunction with a heating pad. Additionally, it is not recommended for use in children under 12 years of age.

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: the condition worsens; redness develops; irritation is experienced; symptoms persist for more than 7 days; or if symptoms resolve only to recur within a few days. Furthermore, patients should seek medical advice if they notice any signs of injury, such as pain, swelling, or blistering at the site of application.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that the product is intended for external use only and should not be applied to wounds or damaged skin. Additionally, it should not be used in conjunction with a heating pad or on children under 12 years of age.

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, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Furthermore, individuals should seek medical attention if they experience signs of injury, such as pain, swelling, or blistering at the site of application.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Natural 17 Herbal Splash (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is advised that healthcare professionals consult a doctor for any pediatric patient in this age group before considering treatment.

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 prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with its use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose effectively.

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 use the product only as directed to ensure safety and efficacy. Patients must be informed of the importance of avoiding contact with eyes and mucous membranes, as this can lead to adverse effects.

In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately. It is crucial for patients to be aware of the signs of an allergic reaction; they should discontinue use and consult a physician if such symptoms occur.

Patients should be cautioned against exposing the treated area to heat or direct sunlight, as this may exacerbate their condition. They should also be instructed to stop use and consult a doctor if their condition worsens, if redness is present, or if irritation develops.

Additionally, patients should be advised to seek medical advice if symptoms persist for more than 7 days or if they clear up only to recur within a few days. They should also be informed to stop use and consult a doctor if they experience any signs of injury, such as pain, swelling, or blistering at the site of application.

Storage and Handling

The product is supplied in a tightly closed container to ensure stability and integrity. It should be stored in a dry place at controlled room temperature, specifically between 59°-86° F (15°-30° C). Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Natural 17 Herbal Splash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)