Medicated Herbal Lip Balm

Description

Earth Mama Medicated Herbal Lip Balm is presented in a carton containing 0.15 oz (4.25 g) of the product. The formulation is designed to provide soothing relief for chapped lips, utilizing a blend of herbal ingredients. The lip balm is packaged in a convenient size suitable for on-the-go application.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, a small amount of the product should be applied to the affected area no more than 3 to 4 times daily. It is essential to wash hands thoroughly before and after the application of the balm to prevent contamination and ensure hygiene. The product should not be shared with others to avoid cross-contamination.

For children under 2 years of age, it is advised to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children. If the condition worsens, or if symptoms persist for more than 7 days or recur after clearing up, discontinue use and consult a healthcare professional. Additionally, avoid contact with eyes.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application to prevent irritation or injury.

Patients should be instructed to discontinue use and consult a healthcare provider if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure appropriate management of the patient's condition.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to mitigate potential health risks associated with ingestion.

Additionally, this product should be stored out of reach of children to prevent accidental exposure or ingestion. Proper education on storage and usage is vital for ensuring safety.

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.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional.

Additionally, this product should be kept out of reach of children. If swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 Medicated Herbal Lip Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended dosage is to apply a small amount of the product to the affected area no 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Medicated Herbal Lip Balm during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential. It is advisable to consider the potential risks and benefits before use in this population, as the lack of data does not preclude the possibility of unknown fetal impacts.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Medicated Herbal Lip Balm. Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers. The potential effects on breastfed infants and the excretion of the product's components in breast milk remain undetermined.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective recovery.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if their condition worsens. Additionally, they should be advised to stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

It is also important to remind patients to avoid contact with their eyes while using this product to prevent irritation or injury.

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 manner that protects it from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the affected area no more than 3 to 4 times daily. Clinicians should advise patients that the product is for external use only and to avoid contact with the eyes. Patients are instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, it is important for patients to keep the product out of reach of children. In the event of ingestion, they should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. Patients should wash their hands before and after applying the balm and refrain from sharing the product with others. For children under 2 years of age, consultation with a doctor is recommended prior to use.

Drug Information (PDF)

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

View product document (PDF)