Healthwise 4% Lidocaine Cream 2.7 Oz

Uses and Indications

This drug is indicated for the temporary relief of minor pain.

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

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication should be applied to the affected area every 6 to 8 hours. The total number of applications must not exceed 3 times within a 24-hour period.

For children 12 years of age or younger, it is recommended to consult a physician prior to use.

Contraindications

Use is contraindicated in the following situations:

Application in large quantities, particularly over raw surfaces or blistered areas, is not recommended due to the potential for increased irritation or adverse effects. The product should not be applied to puncture wounds, as this may lead to complications or infection. Additionally, prolonged use beyond one week without medical consultation is contraindicated to prevent potential adverse reactions or complications.

Warnings and Precautions

For external use only; contact with the eyes must be strictly avoided. The product should not be applied in large quantities, especially on raw surfaces or blistered areas, and is contraindicated for use on puncture wounds.

Healthcare professionals should advise patients to limit the duration of use to no more than one week without prior consultation with a physician. It is imperative that users adhere strictly to the provided instructions, reading and following all directions and warnings on the packaging.

In addition, users should refrain from bandaging or applying local heat, such as heating pads, to the area of application. If the condition worsens or if symptoms persist beyond seven days, or if symptoms resolve and then recur within a few days, patients should discontinue use and seek medical advice.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product. The product must 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 (800-222-1222) is recommended.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only, and contact with the eyes must be strictly avoided. It should not be used in large quantities, particularly over raw surfaces or blistered areas, nor should it be applied to puncture wounds. Additionally, the product should not be used for more than one week without consulting a healthcare professional.

While using this product, it is crucial to adhere to the directions provided. Patients should avoid bandaging the area of application or applying local heat, such as heating pads. If the condition worsens, or if symptoms persist for more than seven days or resolve and then recur within a few days, patients are advised to discontinue use and consult a doctor.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. Furthermore, this product 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 (800-222-1222) is advised.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Healthwise 4% Lidocaine Cream 2.7 Oz (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. For patients over 12 years, the recommended dosage is to apply a thin layer to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

It is essential to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 800-222-1222.

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

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 currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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. 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 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 prescribing information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center at 800-222-1222 is recommended for further guidance and support.

Prompt intervention is essential to manage potential symptoms associated with an overdose effectively. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management procedures based on the severity of the overdose and the specific substance involved.

Nonclinical Toxicology

There are no teratogenic effects observed in the studies conducted. Additionally, no non-teratogenic effects have been reported. The nonclinical toxicology section does not provide any further data. Furthermore, there are no findings related to animal pharmacology and toxicology available in the current dataset.

Postmarketing Experience

No postmarketing experience details are provided 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 of swallowing, patients should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Patients should be instructed not to use this product in large quantities, especially over raw surfaces or blistered areas, and to avoid application on puncture wounds. It is important to inform patients that they should not use the product for more than one week without consulting a doctor.

Healthcare providers should emphasize that patients must stop use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should be reminded to use the product only as directed and to read and follow all directions and warnings on the carton carefully.

Additionally, patients should be cautioned against allowing the product to come into contact with their eyes. They should also be advised not to bandage or apply local heat, such as heating pads, to the area of use.

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), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should apply a thin layer of the medication to the affected area every 6 to 8 hours, ensuring that the total number of applications does not exceed three in a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children; if ingested, medical assistance should be sought immediately or contact a Poison Control Center at 800-222-1222.

Drug Information (PDF)

This file contains official product information for Healthwise 4% Lidocaine Cream 2.7 Oz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)