Gold Ice Pain Relief

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

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. For adults and children aged 12 years and older, it is recommended to consult a physician prior to use. The safety and efficacy of this medication in children under 12 years of age have not been established; therefore, consultation with a healthcare professional is advised before administration in this population.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for irritation or adverse reactions. Tight bandaging is not recommended as it may impede circulation and exacerbate skin irritation. The use of heating pads in conjunction with this product is contraindicated, as it may lead to increased absorption and potential toxicity. Additionally, contact with the eyes or mucous membranes should be avoided to prevent irritation and potential injury.

Warnings and Precautions

For external use only, this product must be handled with caution to ensure safety and efficacy. It is imperative to keep the product away from fire or flame due to its flammable nature. Users should avoid applying the product to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Additionally, it is advised not to bandage the area tightly or use the product in conjunction with a heating pad, as these practices may increase the risk of irritation or burns.

Contact with the eyes or mucous membranes should be strictly avoided to prevent serious complications. The product should be used only as directed to ensure safe application and to minimize the risk of adverse reactions.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if redness or skin irritation develops, it is essential to stop use and consult a healthcare provider.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. Prompt action is crucial to mitigate potential health risks associated with ingestion.

Side Effects

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, the appearance of redness or skin irritation warrants immediate medical advice.

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 Gold Ice 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 physician prior to use. It is essential to consider the specific needs and potential risks associated with this age group when determining treatment options.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, 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 the safety of both the mother and the developing fetus.

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

Patients with renal impairment have not been specifically addressed in the drug insert 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 the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, or if redness or skin irritation develops.

While using this product, patients must be cautioned against applying it to wounds or damaged skin. They should not bandage the area tightly, use it in conjunction with a heating pad, or allow contact with the eyes or mucous membranes. It is essential that patients use the product only as directed to ensure safety and efficacy.

Storage and Handling

The product is supplied in a tightly sealed container and should be stored at room temperature. It is essential to keep the container closed to maintain product integrity. The product must not be used if the plastic seal around the cap is broken or missing. For optimal preservation, it should be stored in a cool, dry place to prevent degradation.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)