Blue Ice Analgesic Gel

Description

SB Blue Ice Gel is a topical formulation designed for external use. It is characterized by its blue color and gel-like consistency. The product is intended for application to the skin and is formulated to provide a cooling sensation upon contact. The specific composition and concentration of active ingredients are proprietary. The gel is packaged in a suitable container to maintain its stability and efficacy during storage and use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

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

Dosage and Administration

Adults and children over 2 years of age should apply the gel liberally to the affected area and massage it into the skin until fully absorbed. This application may be repeated no more than 3 to 4 times daily.

The gel is intended for topical use only. Care should be taken to ensure that the application is performed gently and that the area is not irritated during the massage process.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and mucous membranes. When utilizing this product, healthcare professionals should advise patients against the following practices: using the product in conjunction with heating pads or heating devices; using, pouring, spilling, or storing the product near an open flame; combining it with other creams, sprays, or liniments; applying it to damaged skin or open wounds; and tightly bandaging the area of application. Engaging in any of these actions may lead to excessive skin irritation or burns.

Patients should be instructed to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Individuals with sensitive skin are advised to consult a physician prior to use. Should skin irritation develop, it is essential to discontinue use and seek medical advice before reapplying the product.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Healthcare professionals should emphasize the importance of monitoring the patient's condition and advise them to stop using the product and contact their physician if any of the aforementioned symptoms occur.

Side Effects

Patients should be aware that this product is for external use only and must be applied with caution to avoid contact with eyes and mucous membranes. Serious adverse reactions may occur if the product is used improperly. Specifically, patients are advised against using this product in conjunction with heating pads or heating devices, as well as near open flames. Additionally, it should not be combined with other creams, sprays, or liniments, nor should it be applied to damaged skin or open wounds. Bandaging the area tightly is also discouraged, as these practices may lead to excessive skin irritation or burns.

In clinical observations, if a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended that the patient discontinue use and consult a physician. Patients with sensitive skin should seek medical advice prior to using this product. Should skin irritation develop, it is imperative to discontinue use and consult a physician before reapplying the product.

Drug Interactions

The use of this medication is contraindicated with heating pads or heating devices, as the combination may lead to increased risk of adverse effects. Additionally, it is advised not to use this medication concurrently with other topical formulations such as creams, sprays, or liniments, as this may alter the efficacy or safety profile of the treatment.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not required in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Blue Ice Analgesic Gel (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this product unless specifically advised by a physician. For children aged 2 years and older, the product may be applied liberally to the painful area, with gentle massage until the gel is fully absorbed into the skin. Applications should not exceed 3-4 times daily.

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

There is no specific information available regarding the use of BLUE ICE ANALGESIC GEL during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this product in women of childbearing potential. It is advisable to exercise caution and to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of accidental ingestion of the medication. It is important for patients to understand the potential risks associated with unintentional consumption and to act swiftly to ensure their safety.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its efficacy. Additionally, it is essential to keep the product out of reach of children. Once opened, the product should be discarded to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically, with instructions for adults and children over 2 years of age to apply liberally to the painful area and massage until the gel is absorbed into the skin. This application may be repeated no more than 3-4 times daily.

Clinicians should counsel patients to keep the product out of reach of children. In the event of accidental ingestion, patients are advised to seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Blue Ice Analgesic Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)