Maybelline New York Baby Lips Dr Rescure Menthol External Analgesic Medicated...

Description

The drug is presented in a blister pack, which provides a secure and organized method for dispensing individual doses. The packaging is designed to maintain the integrity of the product and facilitate ease of use. An image of the blister pack, showcasing both the front and back, is available as "MAYDRRESCUE.jpg".

Uses and Indications

This drug is indicated for the temporary relief of pain associated with fever blisters and cold sores.

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

Dosage and Administration

For adult patients, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily. Care should be taken to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in individuals with a known hypersensitivity to any of its components. Additionally, the product should not be applied to the eyes, as this may result in irritation or injury.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek medical assistance immediately or contact a Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. These actions are crucial to ensure patient safety and effective management of their condition.

In cases of ingestion, immediate medical help is necessary. Prompt action is essential to mitigate potential adverse effects associated with swallowing the product.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and 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 Maybelline New York Baby Lips Dr Rescure Menthol External Analgesic Medicated Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 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 is advised.

The product is intended for adult use only, with directions specifying application to the affected area no more than 3 to 4 times daily. There are no established dosing guidelines for pediatric patients, and caution is warranted when considering use in this population.

Geriatric Use

Elderly patients are not specifically addressed in the available prescribing information for this product. The indication is limited to adult use, and there are no recommendations for dosage adjustments or safety considerations tailored for geriatric patients. Healthcare providers should exercise standard clinical judgment when prescribing this product to elderly patients, as individual patient factors may still necessitate careful monitoring and assessment.

Pregnancy

There is no specific information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

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 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 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 substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to understand the necessity of stopping the use of the product and consulting a doctor if their condition worsens. Additionally, patients should be informed to discontinue use and reach out to a healthcare professional if their symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

Providers should also emphasize the importance of avoiding contact with the eyes while using this product, as this could lead to irritation or other complications. Clear communication of these points will help ensure patient safety and effective use of the product.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from excessive heat sources. To maintain product integrity, it is essential to keep the container tightly closed when not in use. Additionally, the product must be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with directions for adult use indicating that it should be applied to the affected area no more than 3 to 4 times daily. 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 Maybelline New York Baby Lips Dr Rescure Menthol External Analgesic Medicated Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)