Super Blue Stuff Pain Relief Cream

Description

The product, identified by SPL code 34089-3, is packaged in a bottle. The effective date of the insert is November 5, 2020.

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. It is essential to ensure that the application is performed gently and uniformly over the affected skin to maximize therapeutic effect. Healthcare professionals should instruct patients to wash their hands before and after application to prevent contamination and avoid contact with eyes and mucous membranes.

Contraindications

Use is contraindicated in patients with wounded, damaged, or irritated skin due to the potential for exacerbation of the condition. Additionally, avoid contact with eyes or mucous membranes, and do not apply a tight bandage, as these practices may lead to adverse effects.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to wounded, damaged, or irritated skin to prevent adverse reactions. Users should take care to avoid contact with the eyes and mucous membranes during application. Additionally, it is advised not to bandage the area tightly after application.

In the event of a rash, worsening condition, or if symptoms persist beyond 10 days or reoccur shortly after resolution, users should discontinue use and seek medical advice. Special consideration should be given to pregnant or breastfeeding individuals; consultation with a healthcare professional is recommended prior to use in these populations.

For pediatric use, it is essential to consult a physician before applying this product to children under 12 years of age if arthritis conditions are present. For all other indications, a healthcare provider should be consulted before use in children under 2 years of age.

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 should be made without delay.

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 the event of a rash or any adverse reaction, or if the condition worsens, patients are advised to discontinue use and consult a healthcare professional. Additionally, if symptoms persist for more than 10 days or if they resolve 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, caregivers should consult a doctor before using this product on children under 12 years of age if arthritis conditions are present. For all other uses, consultation is advised before applying to children under 2 years of age.

It is crucial to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made without delay.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. 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 Blue Stuff Pain Relief Cream (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 doctor prior to use. For all other indications, it is advised that healthcare professionals be consulted before administering the product to children under 2 years of age. Additionally, it is important to keep the product out of reach of children to ensure safety.

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 adverse effects or changes in therapeutic response, 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

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 medication in 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 information available 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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert for SUPER BLUE STUFF Pain Relief Cream.

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, or if symptoms resolve and then recur within a few days.

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.

Additionally, healthcare providers should recommend that patients consult 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 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 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 Blue Stuff Pain Relief Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)