Super White Stuff Pain Relief

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with 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 three to four times daily. Healthcare professionals are advised to instruct patients on the appropriate technique for application to ensure optimal therapeutic effect while minimizing the risk of adverse reactions.

Contraindications

The product is contraindicated for use on wounded, damaged, or irritated skin 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. It is also advised not to apply tight bandages over the area of application, as this may lead to adverse effects.

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, users should refrain from applying tight bandages over the treated area.

In the event of a rash, adverse reaction, worsening of the condition, or if symptoms persist beyond 10 days or reoccur shortly after resolution, it is essential to discontinue use and consult a healthcare professional.

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

Prior to use in children under 12 years of age with arthritis conditions, consultation with a healthcare provider is recommended. For all other applications, it is advisable 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.

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

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. Caution is also 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 necessary for children under 2 years of age.

This product should 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 without delay.

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 with arthritis conditions should consult a healthcare professional prior to use. For all other indications, it is advised that children under 2 years of age also seek medical consultation before use. Additionally, it is important to keep the product out of reach of children to ensure safety.

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. 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 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 a rash or any adverse reaction, if their condition worsens, or if symptoms persist for more than 10 days. Additionally, if symptoms resolve and then recur within a few days, they should also seek medical advice.

While using the product, patients should be cautioned to avoid contact with the eyes and mucous membranes, and they should not apply a tight bandage over the area of application.

For pediatric patients, healthcare providers should recommend consulting a doctor before using the product on children under 12 years of age if arthritis conditions are present. For all other uses listed, it is advised 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; 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 or 4 times a day. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)