Lansinoh Anti-Itch

Description

This pharmaceutical product is identified by the code 51945-4 and is associated with the effective date of May 15, 2024. The product is presented in a dosage form that is visually represented in multiple images, including the drug fact and front, a frontal view, and a display cartoon. The images are in JPEG format and serve to provide a visual reference for the product's labeling and packaging.

Uses and Indications

This drug is indicated for the temporary relief of itching.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication externally to the affected area. Applications should not exceed 3 to 4 times daily. It is important to ensure that the area is clean and dry prior to application. Care should be taken to avoid contact with eyes and mucous membranes.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied in or near the mouth, or on the breasts or nipples during breastfeeding due to potential risks to the infant. Additionally, pregnant women are advised to consult their physician prior to using any over-the-counter drug product to ensure safety for both mother and fetus.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

General precautions must be observed when using this product. It should not be applied in or near the mouth, nor on the breasts or nipples during breastfeeding. Pregnant women are strongly advised to consult their physician prior to using any over-the-counter (OTC) drug product to ensure safety for both mother and fetus.

In the event of accidental ingestion, immediate medical assistance is required. Users should contact a Poison Control Center or seek emergency medical help without delay by calling 1-800-222-1222.

Users should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure the safe and effective use of the product.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. In the event of worsening conditions, persistent symptoms lasting more than 7 days, or if symptoms resolve and then recur within a few days, patients are advised to stop use and consult a doctor.

Additionally, if any adverse reactions occur, it is recommended that patients seek medical advice. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Lansinoh Anti-Itch (menthol 0.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use this medication. It is to be applied externally to the affected area, with a maximum frequency of 3-4 times daily.

Caution is advised to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant women are advised to consult their physician before using any over-the-counter (OTC) drug product. This precaution is essential to ensure the safety of both the mother and the developing fetus, as the effects of many OTC medications during pregnancy may not be fully understood. Healthcare professionals should evaluate the potential risks and benefits of any medication in pregnant patients, considering the lack of comprehensive data on fetal outcomes associated with specific OTC products.

Lactation

Lactating mothers are advised against using this product in or near the mouth, or on the breasts or nipples while breastfeeding. This precaution is essential to ensure the safety of breastfed infants and to prevent any potential adverse effects.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdosage cases. It is critical to document all findings and interventions thoroughly to ensure continuity of care and facilitate any necessary follow-up.

Nonclinical Toxicology

Pregnant women are advised to consult their physician before using any over-the-counter drug product due to potential teratogenic effects. No information regarding non-teratogenic effects or specific animal pharmacology and toxicology studies is available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed that the medication is not to be used in or near the mouth, or on the breasts or nipples while breastfeeding. It is essential for pregnant women to consult their physician before using any over-the-counter drug product to ensure safety for both the mother and the developing fetus.

Healthcare providers should instruct patients to stop using the medication and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. This guidance is crucial for ensuring appropriate use and monitoring of the medication's effects.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and protected from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should apply the medication externally to the affected area no more than 3-4 times daily. Pregnant women are advised to consult their physician prior to using any over-the-counter drug product. It is crucial to keep the medication out of reach of children; if swallowed, medical help should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)