Celadrin

Description

InflameAway® is a deep penetrating joint and muscle pain relieving cream formulated with Celadrin®. This product features a greaseless formula designed for fast-acting relief. It is packaged in a net weight of 6 oz. (170 g).

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times per day. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the use of this product should be discontinued, and a physician should be consulted.

This product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to further complications. Additionally, it is advised not to bandage the area tightly after application, as this may hinder proper healing and increase the risk of adverse effects.

To ensure safety, this product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes. In clinical practice, if the condition worsens, or if symptoms persist for more than 7 days or clear up and then recur within a few days, patients are advised to discontinue use and consult a physician. The product should not be applied to wounds or damaged skin, and it is recommended not to bandage tightly.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a poison control center immediately.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Celadrin (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 per day. For children under 2 years of age, it is advised to consult a physician prior to use. Additionally, the product should be kept out of reach of children to ensure safety.

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, given the lack of targeted data.

Pregnancy

The product has not been evaluated for safety in pregnancy, and therefore, the safety of menthol during this period has not been established. Pregnant patients are advised to consult a healthcare provider before using this product. There are no specific contraindications listed for use during pregnancy, and no dosage modifications for pregnant individuals are provided. Given the lack of established safety data, caution is recommended when considering the use of this product in women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a poison control center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

Patients should be cautioned to avoid contact with their eyes. If they experience any adverse effects or if their condition worsens, they should discontinue use of the product and consult a physician, especially if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Additionally, healthcare providers should inform patients not to apply the product to wounds or damaged skin and to avoid bandaging the area tightly after application.

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 to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains within its specified temperature range and is protected from moisture.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times per day. For children under 2 years of age, consultation with a physician is recommended prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)