Reactice

Description

Reactivating Ice Baume is an external analgesic formulated to provide relief from discomfort. The product is presented in a dosage form of 16 fluid ounces (473 mL).

Uses and Indications

This drug is indicated for use as an external analgesic. There are no teratogenic effects associated with this medication, nor are there any nonteratogenic effects reported.

Dosage and Administration

The cream should be applied to sore muscles and joints, with gentle massage into the skin as needed. For adults and children aged 2 years and older, the cream may be applied to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. In the event of accidental eye contact, immediate rinsing with water is recommended.

It is essential for users to wash their hands thoroughly after each application to prevent unintended exposure to other areas of the body or to other individuals.

In cases of ingestion, patients should seek medical assistance immediately or contact poison control for guidance.

Pregnant or nursing individuals are advised to consult with their healthcare provider prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes during application. Following each use, patients are advised to wash their hands thoroughly to prevent unintended exposure.

In the event of accidental ingestion, immediate medical assistance should be sought, or poison control should be contacted without delay. Additionally, pregnant or nursing individuals are encouraged to consult their healthcare provider prior to using this product to ensure safety for both themselves and their child.

Drug Interactions

No drug interactions have been identified for the product, indicating that it does not have any known pharmacodynamic or pharmacokinetic interactions with other medications. Additionally, there are no reported 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 Reactice (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

There is no specific information available 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 nursing mothers are advised to seek the advice of their healthcare provider prior to using this product. The potential risks and benefits should be carefully considered, as the effects on fetal outcomes and nursing infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare professional to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to seek the advice of their healthcare provider before using this product. There is no specific data available regarding the excretion of this product in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this product during lactation.

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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact poison control without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Healthcare providers should monitor for any adverse effects and be prepared to manage symptoms as they arise.

Management of overdosage should include supportive care and symptomatic treatment. It is crucial to follow established protocols for the specific substance involved, which may include activated charcoal administration if appropriate and within the recommended time frame post-ingestion. Continuous monitoring of vital signs and supportive measures should be implemented as necessary.

In summary, prompt action and appropriate medical intervention are critical in the management of overdosage cases to mitigate potential complications and ensure patient safety.

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 keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically for adults and children aged 2 years and older, with a recommended application frequency of 3 to 4 times daily to the affected area. Clinicians should advise patients to keep the product out of reach of children and to consult a doctor if conditions worsen or persist beyond 7 days. It is for external use only; patients should avoid contact with eyes and wash hands thoroughly after use. In the event of ingestion, immediate medical assistance or contact with poison control is necessary. Pregnant or nursing patients are advised to seek their doctor's guidance before using the product.

Drug Information (PDF)

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

View product document (PDF)