Personal Care Ice Cold

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "A" on one side and "123" on the opposite side. It contains 500 mg of Acetaminophen as the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor muscle aches and pains associated with various conditions, including arthritis, simple backache, strains, bruises, sports injuries, and sprains. It provides cooling, penetrating relief to affected areas.

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

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 2 years and older, the product may be applied to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Application near the eyes is prohibited due to the potential for irritation or damage to ocular tissues. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or hinder healing. Additionally, tight bandaging of the area where the product is applied is contraindicated, as it may lead to increased pressure and potential adverse effects.

Warnings and Precautions

For external use only. This product should not be used in conjunction with other topical pain relievers, heating pads, or heating devices, as this may increase the risk of adverse effects.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, any development of redness or irritation should prompt immediate cessation of use and a consultation with a physician.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in conjunction with other topical pain relievers, as well as with heating pads or heating devices, due to the potential for increased adverse reactions.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, or the development of redness or irritation at the application site. These reactions warrant medical evaluation to ensure appropriate management and to rule out any serious underlying conditions.

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated due to the potential for increased local irritation or adverse effects. It is advised to avoid the simultaneous use of heating pads or other heating devices, as this may enhance the risk of skin irritation or burns.

Monitoring for signs of local adverse reactions is recommended when this medication is used, particularly in patients who may be using other topical agents or heat sources.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 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

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 established 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be maintained until the patient stabilizes or further treatment is determined.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 for patients to understand that they should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should also be informed to watch for any signs of redness or irritation and to stop using the product if these occur.

Additionally, healthcare providers should instruct patients to avoid using the product in or near the eyes, as well as on wounds or damaged skin. It is crucial to emphasize that patients should not apply a tight bandage over the area where the product is used. Clear communication of these points will help ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a tightly closed container and should be stored at a controlled room temperature of 20 to 25℃ (68 to 77°F). It is essential to ensure that the container remains tightly closed to maintain the integrity of the product.

Special handling precautions must be observed; the product should not be used, poured, spilled, or stored near heat sources or open flames to prevent any potential hazards.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, clinicians are advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)