Get-Gone - Acne Body Cleanser

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the treatment of acne. There are no teratogenic effects associated with its use, and no nonteratogenic effects have been reported.

Dosage and Administration

The product should be applied during a shower. Users are instructed to lather the product with water, ensuring it is adequately mixed. It is essential to massage the lathered product evenly over the wet skin, with particular attention given to areas affected by acne. After massaging, the product must be rinsed off thoroughly to ensure complete removal from the skin.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with the eyes should be strictly avoided. In cases of excessive skin irritation or if irritation worsens, discontinue use immediately and seek medical advice. If the product is ingested, prompt medical assistance should be sought or the local Poison Control Center contacted.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid concurrent use of other topical acne medications, as this may exacerbate skin dryness or irritation. In such cases, it is recommended that only one medication be utilized unless otherwise directed by a physician.

Care should be taken to prevent contact with the eyes. In the event of accidental exposure, patients should be instructed to rinse thoroughly with water.

Should excessive skin irritation develop or worsen, patients must discontinue use immediately and seek medical advice.

In the case of ingestion, it is imperative to obtain medical assistance or contact a Poison Control Center without delay.

Side Effects

For external use only. Patients using this product may experience increased dryness or irritation of the skin, particularly if other topical acne medications are used concurrently or immediately following application. In such cases, it is advised that only one medication be utilized unless directed otherwise by a healthcare professional.

Participants should avoid contact with the eyes. Should excessive skin irritation develop or worsen, it is recommended to discontinue use and consult a healthcare provider. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

Concurrent use of other topical acne medications with this product may lead to increased dryness or irritation of the skin. It is advisable to limit the use of multiple topical agents to one at a time unless otherwise directed by a healthcare professional. Monitoring for signs of excessive dryness or irritation is recommended to ensure patient comfort and skin health.

Packaging & NDC

Below are the non-prescription pack sizes of Get-Gone - Acne Body Cleanser (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that the product is swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Geriatric Use

There is no specific information regarding the use of Get-Gone - Acne Body Cleanser in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when considering the use of this product in individuals aged 65 and older, as the absence of data necessitates careful monitoring and assessment of the patient's response to treatment.

Pregnancy

The safety of salicylic acid during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus, including the possibility of teratogenic effects. Pregnant patients are advised to consult a healthcare provider before using this product. It is recommended that the use of salicylic acid during pregnancy be avoided unless specifically directed by a healthcare professional.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

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

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific product and the amount ingested; therefore, a thorough assessment by a medical professional is recommended.

Management procedures will typically involve supportive care and symptomatic treatment as necessary. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that the concurrent use of other topical acne medications with this product may lead to increased dryness or irritation of the skin. Patients should be instructed to use only one medication at a time unless otherwise directed by a healthcare professional.

It is important to inform patients to avoid contact with the eyes. In the event that excessive skin irritation develops or worsens, patients should discontinue use of the product and seek medical advice.

Additionally, healthcare providers should counsel patients on the importance of seeking immediate medical assistance or contacting a Poison Control Center if the product is swallowed.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. 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

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Get-Gone - Acne Body Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)