Rapid Relief Cold Relief Patch

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 12 years and older, the following dosage and administration guidelines apply:

The patch should be applied to the affected area after carefully removing the backing. The sticky side of the patch must be placed directly onto the skin. Each patch may be worn for a maximum of 8 hours. If necessary, the application may be repeated, but no more than three patches should be used in a 24-hour period. After a single use, the patch must be discarded appropriately. It is important to reseal the pouch after opening to maintain the integrity of the remaining patches.

For children under 12 years of age, it is recommended to consult a physician prior to use.

Contraindications

The product is contraindicated in the following situations:

Use is contraindicated on wounds, cuts, damaged, or infected skin due to the risk of exacerbating the condition and potential for systemic absorption. Application to the eyes, mouth, genitals, or any other mucous membranes is also contraindicated to prevent irritation and adverse reactions.

Additionally, the product should not be used in conjunction with other topical analgesics, as this may increase the risk of adverse effects. Bandaging tightly or using with a heating pad is contraindicated, as it may lead to increased absorption and potential toxicity.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds, cuts, damaged, or infected skin. It should not be applied to the eyes, mouth, genitals, or any other mucous membranes.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens; redness is observed; irritation develops; symptoms persist for more than 7 days or resolve and then recur within a few days; or if signs of skin injury, such as pain, swelling, or blistering, are experienced at the site of application. Additionally, pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted without delay.

Side Effects

Patients should be aware that the product is intended for external use only.

In clinical practice, it is advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, which may include pain, swelling, or blistering at the site of application.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use to ensure safety and appropriateness of the product.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and efficacy of treatment. Monitoring for any signs of increased irritation or adverse reactions is recommended if there is a potential overlap in the use of topical analgesics.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may use this medication. For children under 12 years of age, it is recommended to consult a physician prior to use.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the provided drug insert. Therefore, healthcare providers may consider the standard dosing guidelines applicable to this population without the need for modifications based on age alone. However, as with all medications, it is advisable to monitor elderly patients closely for any potential adverse effects or changes in therapeutic response, given the variability in pharmacokinetics and pharmacodynamics that may occur with aging.

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 breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring informed decision-making for both maternal and fetal health.

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 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 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 measures be employed. This includes ensuring the patient's safety, providing symptomatic treatment, and considering consultation with a poison control center or a medical toxicologist for further guidance.

Healthcare providers should remain vigilant and document any observed symptoms, as well as the patient's response to any interventions undertaken.

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

Serious burns have been reported in rare cases associated with the use of products of this type. These events were documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 if the product is swallowed. It is important to instruct patients not to use the product on wounds, cuts, damaged, or infected skin, and to avoid application on the eyes, mouth, genitals, or any other mucous membranes.

Patients should be informed to discontinue use and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, they should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

For patients who are pregnant or breastfeeding, it is essential to recommend consulting a healthcare professional before using the product. When using this product, patients should be instructed to use it only as directed. They should be made aware that rare cases of serious burns have been reported with similar products. It is crucial to advise against tightly bandaging the area or using a heating pad in conjunction with the product. Patients should also be reminded to avoid contact with eyes and mucous membranes, refrain from applying it to wounds or damaged skin, and not to use it simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15-30℃ (59-86℉) to maintain its efficacy. Additionally, the product should be kept out of reach of children to ensure safety. Proper handling and storage conditions are crucial for preserving the integrity of the product.

Additional Clinical Information

The product is administered topically, with a recommended usage of one patch for up to 8 hours. Patients may repeat this application as necessary, but should not exceed three applications in a single day.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding prior to use. It is also crucial to advise patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 if the product is swallowed.

Drug Information (PDF)

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

View product document (PDF)