Bellehaven Numbing Cream

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of localized pain, itching, or discomfort associated with minor skin irritations.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to apply the cream externally to the affected area up to four times daily. For children under 12 years of age, it is recommended to consult a doctor prior to use.

When utilizing finger cots for application, healthcare professionals should advise patients to roll one finger cot to cover the finger adequately. Following this, a small amount of cream should be gently squeezed onto the finger cot, and a smooth layer of the cream should be applied to the affected area.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Additionally, the following precautions must be observed:

• Avoid contact with the eyes, as this may lead to irritation or injury.

• Do not exceed the recommended dosage unless specifically directed by a healthcare professional, due to the potential for adverse effects.

• The product should not be administered rectally using fingers, mechanical devices, or applicators, as this may result in complications or injury.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, immediate medical assistance should be sought.

Healthcare professionals should advise patients to exercise caution and refrain from using this product if they have a known allergy to any of its ingredients.

Patients are instructed to discontinue use and consult a physician if any of the following occur: the condition worsens or fails to improve within 7 days; an allergic reaction to the product's ingredients manifests; the symptoms being treated do not subside, or if any signs of redness, irritation, swelling, pain, or other adverse effects develop or intensify; or if symptoms resolve and then recur within a few days.

In cases of ingestion, it is imperative to seek emergency medical help immediately.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens or does not improve within 7 days; an allergic reaction to the ingredients in this product develops; the symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase; or if symptoms clear up and then return within a few days.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Bellehaven Numbing Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the medication may be applied externally to the affected area up to four times a day.

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 adverse effects or changes in therapeutic response, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise. In the event of suspected overdosage, it is recommended to initiate supportive care and symptomatic treatment as necessary.

Healthcare providers should consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the specific situation. Continuous assessment of the patient's clinical status is essential to ensure appropriate interventions are implemented promptly.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek medical help immediately if the product is swallowed. It is important to inform patients not to use the product if they have a known allergy to any of its ingredients.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens or does not improve within 7 days; an allergic reaction to the ingredients develops; the symptoms being treated do not subside, or if any redness, irritation, swelling, pain, or other symptoms develop or increase; or if symptoms clear up and then return within a few days.

Providers should emphasize the importance of avoiding contact with the eyes and advise patients not to exceed the recommended dosage unless directed by a healthcare professional. Additionally, patients should be cautioned against inserting the product into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in packaging that ensures integrity and safety. It should be stored at room temperature, specifically within the range of 59°F to 86°F (15°C to 30°C). Care should be taken to avoid exposure to direct sunlight, as this may affect the product's quality.

Healthcare professionals are advised not to use the product if the tamper-evident packaging has been breached or is missing, as this may compromise the product's safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)