Blue Ice

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 pains of muscles and joints associated with conditions such as simple back ache, arthritis, and sprains, strains, or bruises.

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

Dosage and Administration

For adults and children aged 2 years and older, the affected area should be cleaned thoroughly prior to application. The product should be applied liberally to the affected area, not exceeding 3 to 4 times daily. There is no need for a protective cover after application. The product may be used in conjunction with ice packs for additional relief. If desired, it can also be applied with a wet or dry bandage; however, it is important to wrap the bandage loosely to avoid constriction.

For children under 2 years of age, it is recommended to consult a healthcare professional before use. The route of administration is topical, and the frequency of application should not exceed 3 to 4 times daily.

Contraindications

The product is contraindicated for internal use. It should not be applied in conjunction with heating pads or other heating devices, as this may lead to adverse effects. Additionally, the product must not be used on wounds or damaged skin to prevent potential complications.

Warnings and Precautions

For external use only; direct contact with the eyes should be avoided to prevent irritation or injury.

General precautions must be observed to ensure safe use of this product. It should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted. This product is not intended for internal use and should not be applied in conjunction with heating pads or other heating devices. It is contraindicated for use on wounds or damaged skin. Users are advised to apply the product strictly as directed and to avoid tight bandaging. Care should be taken to prevent contact with eyes and mucous membranes. Individuals with sensitive skin should consult a healthcare professional prior to use.

No specific laboratory tests are recommended for monitoring during the use of this product.

Side Effects

Patients should be advised that the product is for external use only and must be kept away from the eyes to prevent irritation or injury.

It is recommended that individuals with sensitive skin consult a healthcare professional prior to use to ensure safety and appropriateness of the product for their specific skin type.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there is no information regarding interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication liberally to the affected area up to 3-4 times daily. For infants and children under 2 years of age, it is advised to consult a doctor prior to use.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center for guidance.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that standard supportive care measures be implemented. This may include symptomatic treatment and monitoring of vital signs. If an overdose is suspected, healthcare providers should consider contacting a poison control center or seeking guidance from a medical toxicologist for further management strategies.

As always, maintaining a thorough understanding of the patient's medical history and current medications is essential in managing any potential overdosage scenarios effectively.

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 fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to use the product internally or in conjunction with heating pads or devices. It is important to inform patients that the product should not be applied to wounds or damaged skin. When using the product, patients must adhere strictly to the directions provided and should avoid bandaging the area tightly.

Healthcare providers should also emphasize the importance of avoiding contact with the eyes and mucous membranes. Additionally, patients with sensitive skin should be encouraged to consult their doctor before using the product to ensure safety and appropriateness.

Storage and Handling

The product is supplied in a tightly closed container to maintain its integrity. It should be stored at a temperature range of 59°F to 85°F (15°C to 30°C). Care should be taken to avoid exposure to heat or open flames; therefore, it is essential not to use, pour, spill, or store the product in proximity to such hazards.

Additional Clinical Information

The product is administered topically, with a recommended application of 3-4 times daily to the affected area. Clinicians should advise patients that the product is for external use only and caution against contact with the eyes. It should not be used internally, in conjunction with heating pads or devices, or on wounds or damaged skin.

Patients are encouraged to consult a healthcare professional prior to use if they have sensitive skin, are pregnant, or are breastfeeding. Additionally, it is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)