Herb Street Backache and Sore Muscle Relief

Description

Herb Street with Hemp Seed Oil Moisturizer is a topical analgesic stick formulated to provide relief from backache and sore muscles. Each stick contains 10% menthol, contributing to its analgesic properties. The product is presented in a no-mess stick format, with a net weight of 0.59 oz (16.8 g). It is manufactured by Balassa Laboratories, Inc., located at PO Box 291161, Port Orange, FL 32129, and is made in the USA from both US and imported materials. All rights, copyrights, and trademarks are owned by Balassa Laboratories, Inc.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including simple backache, arthritis, bruises, 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 older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to application.

For children under 12 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. Additionally, the application of the product in conjunction with a heating pad is contraindicated, as this may increase the risk of skin burns or other adverse effects.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Users must avoid contact with the eyes and mucous membranes, and it is advised not to apply tight bandages over the treated area.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, development of redness or severe skin irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it 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.

During use, patients are advised to follow the directions provided and to avoid contact with the eyes and mucous membranes. Additionally, it is important not to bandage the area tightly.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, redness or severe skin irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. Furthermore, this 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.

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 Herb Street Backache and Sore Muscle Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For adolescents aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. Care should be taken to adhere to these guidelines to ensure safety and efficacy in this age group.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients provided in the drug insert. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek guidance to ensure the safety of both the mother and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients 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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important for patients to understand that they should stop using the product and consult a doctor if their condition worsens, if they experience redness or severe skin irritation, or if symptoms persist for more than 7 days. Additionally, patients should be informed to seek medical advice if symptoms clear up and then recur within a few days.

When using this product, patients must be reminded to follow the directions provided and to avoid contact with the eyes and mucous membranes. Furthermore, they should not bandage the area tightly while using the product to ensure safety and effectiveness.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, the use of this medication is not recommended without consulting a doctor. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Herb Street Backache and Sore Muscle Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)