Rite Aid Roll-on

Description

RA_cold-therapy-roll-on_2.5 is a topical formulation designed for localized cold therapy. The product is presented in a roll-on dosage form, facilitating targeted application. It is specifically formulated to provide relief from discomfort associated with minor aches and pains. The active ingredients work synergistically to deliver effective cold therapy, while the overall composition ensures ease of use and optimal skin compatibility. The product is characterized by its convenient packaging, allowing for straightforward application in various settings.

Uses and Indications

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

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

Application of this product is contraindicated in the following situations:

• Application to wounds or damaged skin is prohibited due to the risk of exacerbating injury or infection.

• Use on irritated skin or in cases where excessive skin irritation develops is contraindicated to prevent further irritation or adverse reactions.

• Concurrent use with other ointments, creams, sprays, or liniments is not recommended, as this may lead to unpredictable interactions or reduced efficacy.

• Bandaging over the application site is not advised, as it may trap heat and moisture, increasing the risk of skin irritation.

• The use of heating pads or devices in conjunction with this product is contraindicated due to the potential for increased skin irritation or burns.

Additionally, avoid contact with eyes or mucous membranes to prevent irritation or injury.

Warnings and Precautions

For external use only. This product is flammable; it must be kept away from excessive heat or open flame to prevent fire hazards.

Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin. During the application of this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Additionally, it is important to refrain from applying the product to irritated skin or if excessive skin irritation develops. Bandaging the area after application is not recommended. Patients should wash their hands thoroughly with cool water after use and should not use the product in conjunction with heating pads or devices.

Patients are instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only and is flammable; it should be kept away from excessive heat or open flame. Prior to use, individuals with sensitive skin should consult a doctor.

During application, it is crucial to avoid contact with the eyes or mucous membranes and to refrain from applying the product to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be applied to irritated skin or if excessive skin irritation develops. Bandaging the area after application is not recommended, and hands should be washed with cool water following use. Additionally, the product should not be used with heating pads or devices.

Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using this product.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to altered absorption and increased risk of adverse effects.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The use of heat may enhance the absorption of the medication, potentially leading to increased systemic exposure and heightened risk of side effects.

It is advised to monitor for any signs of adverse reactions when using this medication, particularly in the context of its application with other topical agents or heat sources.

Packaging & NDC

Below are the non-prescription pack sizes of Rite Aid Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended dosage is to apply a thin film over the affected areas up to four times daily. Massage of the application site is not necessary.

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, 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. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. 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 to ensure safety and efficacy.

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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are essential to ensure patient safety and effective resolution of any complications arising from the 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 accidentally ingested. Patients should be informed that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur, they should consult their healthcare provider.

It is important to instruct patients to avoid contact with their eyes or mucous membranes and to refrain from applying the product to wounds or damaged skin. Patients should be cautioned against using the product in conjunction with other ointments, creams, sprays, or liniments, as well as on irritated skin or if excessive skin irritation develops. Additionally, patients should be advised not to bandage the area after application.

Healthcare providers should emphasize the importance of washing hands with cool water after using the product. Patients should also be informed not to use the product with heating pads or devices, particularly if they have sensitive skin.

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 in a cool, dry place, away from excessive heat or open flame to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Rite Aid Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)