Menthol

Description

75823-102-01 Rhinitis Support Cream is a topical formulation designed to provide relief from symptoms associated with rhinitis. The cream is presented in a convenient dosage form, allowing for easy application. Its specific composition and formulation details are tailored to address the discomfort associated with nasal congestion and irritation.

Uses and Indications

This product is indicated for the management of various nasal and respiratory conditions based on the principles of "nasal lung coherence" derived from traditional Chinese herbal medicine. It is formulated to assist in the removal of wind and phlegm, balance Yin and Yang, alleviate lung heat accumulation, and promote the repair of nasal mucosa.

This product is effective in relieving symptoms associated with:

• Sneezing

• Runny nose

• Nose bleeding

• Dry nose

• Itchy eyes

• Acute and chronic rhinitis

• Hay fever

• Allergic rhinitis

• Sinusitis

• Nasal polyps

• Pharyngitis

There are no teratogenic or nonteratogenic effects reported for this product.

Dosage and Administration

Healthcare professionals are advised to ensure the nasal cavity is thoroughly cleaned prior to the application of this product. The product should be applied evenly within the nasal cavity. Following application, a gentle massage of the area is recommended to facilitate optimal absorption.

The product is to be administered 2 to 3 times daily, depending on the clinical needs of the patient.

Contraindications

Use is contraindicated in individuals with a nasal injury due to the potential for exacerbating the condition.

Additionally, the product should not be used concurrently with other ointments, sprays, or liniments, as this may lead to adverse interactions.

In pregnant or breastfeeding individuals, consultation with a healthcare professional is advised prior to use to ensure safety for both the mother and child.

Warnings and Precautions

The product is indicated solely for nasal problems. It is essential to note that the formulation is flammable; therefore, it must be kept away from excessive heat or open flames. During the initial stages of use, patients may experience slight sensations of heat, coolness, and numbness, as well as an increase in nasal discharge and sneezing. These reactions are considered normal and typically subside as symptoms improve.

Caution is advised against the concurrent use of this product with other ointments, sprays, or liniments. Additionally, individuals with nasal injuries should refrain from using this product. Pregnant or breastfeeding individuals are encouraged to consult a healthcare professional prior to use to ensure safety.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. Should the product come into contact with the eyes, usage must be discontinued, and the eyes should be rinsed thoroughly with water.

Side Effects

Patients may experience a range of adverse reactions during the use of this product. In the early stages of use, common reactions include slight stimulation of heat, coolness, and numbness, as well as increased runny nose and sneezing. These effects are considered normal and typically resolve as symptoms diminish.

It is important to note that the product is flammable; therefore, patients should keep it away from excessive heat or open flame to avoid potential hazards. In the event of contact with the eyes, patients are advised to discontinue use immediately and rinse the eyes thoroughly with water to mitigate any adverse effects.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, sprays, or liniments, is not recommended. The combination may lead to altered efficacy or increased risk of adverse effects due to potential interactions at the application site. It is advisable to avoid concurrent use to ensure optimal therapeutic outcomes and minimize the risk of skin irritation or other localized reactions.

Packaging & NDC

Below are the non-prescription pack sizes of Rhinitis Support Cream. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on the clinical scenario.

Furthermore, it is recommended that healthcare professionals consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved in the overdose. Documentation of the incident and any interventions performed is crucial for ongoing patient care and for informing future treatment decisions.

Overall, vigilance and prompt action are key in managing potential overdose situations effectively.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section, nor is there any data available concerning animal pharmacology and toxicology.

Postmarketing Experience

In the early stages of use, slight stimulation of heat, coolness, and numbness has been reported, along with an increase in runny nose and sneezing. These events are considered normal responses and typically resolve as symptoms diminish.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this product in conjunction with other ointments, sprays, or liniments. Additionally, individuals with a nasal injury are prohibited from using this product. Pregnant or breastfeeding patients should be encouraged to consult a healthcare professional before use.

Healthcare providers should instruct patients to avoid contact with the eyes while using this product. In the case of accidental eye contact, patients should stop using the product and rinse their eyes thoroughly with water.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the lid is closed tightly to maintain the integrity of the product. Proper storage conditions are critical to preserving the quality and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended frequency of 2-3 times a day. Clinicians should advise patients to avoid contact with the eyes; in the event of contact, patients should stop use and rinse their eyes thoroughly with water. It is crucial to keep the product out of reach of children, and if ingested accidentally, medical assistance or contact with a Poison Control Center should be sought immediately.

Patients are also cautioned against using the product in conjunction with other ointments, sprays, or liniments. Additionally, individuals with nasal injuries are prohibited from using this product. Pregnant or breastfeeding patients should consult a healthcare professional prior to use.

Drug Information (PDF)

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

View product document (PDF)