Super White Stuff Pain Relief

Description

The product is identified by SPL code 34089-3 and is presented as a sterile, non-pyrogenic, isotonic solution. It contains sodium chloride, a common electrolyte, and is characterized by its clear and colorless appearance. The pH of the solution ranges from 4.5 to 7.0. It is packaged in a 130 mL container, with inactive ingredients comprising sodium chloride and water for injection.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including arthritis, simple backache, sprains, strains, and bruises.

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

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. Healthcare professionals are advised to consult a physician prior to use in children under 12 years of age for arthritic conditions, and for all children under 2 years of age for any other indications.

Contraindications

Use of this product is contraindicated on wounded, damaged, or irritated skin due to the potential for exacerbating the condition.

During application, contact with eyes or mucous membranes should be avoided to prevent irritation or adverse reactions. Additionally, tight bandaging is contraindicated as it may lead to compromised circulation or increased local irritation.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounded, damaged, or irritated skin.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, it is advised not to apply a tight bandage over the treated area.

Users should discontinue use and seek medical advice if a rash or any adverse reaction occurs, if the condition worsens, or if symptoms persist for more than 10 days. If the symptoms resolve and then recur within a few days, medical consultation is also recommended.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Prior to use in children under 12 years of age with arthritis conditions, consultation with a healthcare professional is necessary. For all other applications, it is recommended to consult a doctor before using this product on children under 2 years of age.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounded, damaged, or irritated skin. During use, it is important to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area of application.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience a rash or any adverse reaction. Additionally, if the condition worsens or symptoms persist for more than 10 days, or if symptoms clear up and then recur within a few days, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use. Furthermore, caution is advised when considering this product for children; a doctor should be consulted before use in children under 12 years of age if arthritis conditions are present, and for all other uses, consultation is recommended for children under 2 years of age.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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 Super White Stuff Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should be evaluated by a healthcare professional prior to the use of this medication if they have arthritis conditions. For all other indications, consultation with a doctor is advised for children under 2 years of age.

It is essential to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 specific data available regarding the excretion of this drug in 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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.

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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product to wounded, damaged, or irritated skin to prevent further complications.

Patients should be informed to discontinue use and consult a doctor if they experience any rash or adverse reaction. Additionally, they should be advised to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than 10 days, or if symptoms clear up and then recur within a few days.

While using the product, patients must be cautioned to avoid contact with the eyes and mucous membranes. They should also be instructed not to bandage the area tightly to allow for proper ventilation and absorption.

For pediatric patients, healthcare providers should recommend consulting a doctor before use in children under 12 years of age if arthritis conditions are present. For all other uses listed, it is advisable to consult a doctor before using the product on children under 2 years of age.

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 should apply the medication to the affected area no more than 3 to 4 times a day. Clinicians are advised to counsel patients regarding the use of the medication during pregnancy or breastfeeding, recommending consultation with a health professional in such cases. Additionally, it is important to consult a doctor before using the medication on children under 12 years of age if arthritis conditions are present, and for all other listed uses, a consultation is necessary for children under 2 years of age.

Drug Information (PDF)

This file contains official product information for Super White Stuff Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)