Super White Stuff Pain Relief

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 is contraindicated in the following situations:

Application on wounded, damaged, or irritated skin is prohibited due to the potential for exacerbating the condition and delaying healing. Additionally, contact with eyes or mucous membranes should be avoided to prevent irritation or injury. Tight bandaging is also contraindicated, as it may lead to compromised circulation and increased risk of adverse effects.

Warnings and Precautions

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

When using this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, users should refrain from applying tight bandages over the treated area.

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

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

Consultation with a healthcare professional is advised prior to use in children under 12 years of age if arthritis conditions are present. For all other indications, it is recommended to consult a doctor before using this product in children under 2 years of age.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounded, damaged, or irritated skin. During use, patients should avoid contact with eyes or mucous membranes and should not bandage the area tightly.

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

Special precautions should be taken when considering use in children. It is recommended that a doctor be consulted before use in children under 12 years of age if arthritis conditions are present. For all other listed uses, consultation with a healthcare provider is advised prior to use in children under 2 years of age.

In case of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified 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 before using 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 important to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have arthritis conditions and are under 12 years of age. Additionally, for all other indications listed, it is advised that a healthcare provider be consulted before administering this medication to children under 2 years of age.

It is essential for healthcare providers to consider these recommendations when prescribing this medication to ensure the safety and efficacy of treatment in geriatric patients. Monitoring for potential adverse effects and adjusting dosages as necessary may be warranted based on individual patient assessments.

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. 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 currently 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 have not been specifically addressed in the drug insert text 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 there is no available data to guide dosing or monitoring in this population.

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 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 provided 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, if symptoms persist for more than 10 days, or if symptoms clear up only to 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 healing and to prevent any adverse effects.

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, 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 available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard 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 to consult a doctor before use on children under 12 years of age if arthritis conditions are present. Additionally, for all other listed uses, a consultation with a doctor is recommended prior to use on 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)