Celadrin

Description

This formulation contains aloe vera gel and a proprietary blend of esterified fatty acids known as Celadrin® (7.5%). Additional components include cetyl alcohol, glyceryl stearate, stearic acid, and stearyl alcohol, which serve as emulsifiers and stabilizers. The product is enhanced with various essential oils, including cinnamon oil, eucalyptus oil, peppermint oil, tea tree oil, and wintergreen oil, contributing to its aromatic properties.

The formulation also incorporates grape seed oil, jojoba oil, and squalane, which are known for their moisturizing benefits. Hypromellose is included as a thickening agent, while potassium sorbate acts as a preservative. Vegetable glycerin is present to provide additional hydration. The base of the formulation consists of purified water, ensuring a suitable medium for the active ingredients.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as 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 dosage is to 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 physician prior to use.

The medication is intended for topical administration only. Care should be taken to apply the product directly to the affected area, ensuring that the skin is clean and dry before application.

Contraindications

The use of this product is contraindicated in patients with wounds or damaged skin due to the potential for adverse effects and impaired healing. No other contraindications have been specified.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, patients should seek medical advice. Monitoring for these conditions is essential to ensure safe and effective use of the product.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then occur again within a few days, medical advice should be sought.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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

There is no specific information regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

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 this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion or misuse. Patients should be instructed not to apply the product on wounds or damaged skin, as this may lead to adverse effects.

Patients should be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be made aware that if symptoms improve and then recur within a few days, they should also seek medical advice.

While using this product, patients must be cautioned to avoid contact with the eyes and mucous membranes, as this could cause irritation or other complications. Furthermore, they should be advised against tightly bandaging the area where the product is applied to ensure proper air circulation and to prevent potential skin issues.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain product integrity. The tube should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, any unused product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a physician prior to use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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)