Butt and Thighs

Description

SEROFLORA BUTT AND THIGHS is a topical acne treatment cream formulated specifically for the buttocks and thighs. The product is presented in a 4-ounce container and is designed to address acne concerns in these areas. The cream's formulation is intended for external use, and it is packaged in a manner that ensures ease of application. The reference image associated with this product is labeled as FD-04088 BUTT THIGHS ACNE TREATMENT CREAM 82767-002-04.jpg, which provides a visual representation of the product for identification purposes.

Uses and Indications

This drug is indicated for the treatment of acne.

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

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of the product. The affected area should be covered with a thin layer of the product, applied one to three times daily, depending on the patient's needs and the physician's recommendations.

Initial treatment should begin with one application per day. Based on the patient's response and as directed by a healthcare provider, the frequency may be gradually increased to two or three times daily.

In cases where bothersome dryness or peeling occurs, it is advisable to reduce the application frequency to once daily or every other day to mitigate these effects.

Contraindications

Use of this product is contraindicated in patients who experience worsening of their condition or lack of improvement with regular use as directed. Additionally, concurrent use with another topical acne medication may increase the risk of skin irritation and dryness; therefore, only one topical acne medication should be used at a time to minimize these risks.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product on children under 12 years of age unless specifically directed by a physician.

In the event of accidental ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens or fails to improve with regular application of the product as directed. Monitoring for these signs is essential to ensure patient safety and effective treatment outcomes.

Side Effects

Patients should be aware that this product is for external use only and is not recommended for use on children under 12 years of age unless directed by a doctor.

In the event that the condition worsens or does not improve with regular use of this product as directed, patients are advised to stop use and consult a doctor.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate this risk, it is advised that only one topical acne medication be used at a time. If irritation occurs, discontinuation of one of the medications is recommended to allow the skin to recover. Monitoring for signs of irritation is essential to ensure patient comfort and treatment efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Butt and Thighs (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication unless directed by a healthcare professional. Caution is advised when considering treatment in this age group, and appropriate medical guidance is essential to ensure safety and efficacy.

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, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding 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

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare professional before use. Users should discontinue use and seek medical advice if their condition worsens or does not improve with regular application of the product as directed. The likelihood of skin irritation and dryness may increase if another topical acne medication is used concurrently. In the event of irritation, it is recommended to use only one topical acne medication at a time.

No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided in the context of animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 or does not improve with regular use as directed.

Additionally, healthcare providers should inform patients that the likelihood of skin irritation and dryness may increase if they are using another topical acne medication concurrently. In the event that irritation occurs, patients should be instructed to use only one topical acne medication at a time to minimize the risk of adverse effects.

Storage and Handling

The product is supplied in a tube, with the lot number and expiration date clearly indicated on the top of the container. It is essential to protect the product 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

No further data are available.

Drug Information (PDF)

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

View product document (PDF)