Acne Control

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, povidone, talc, 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 this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

The affected area should be covered with a thin layer of the product one to three times daily. It is recommended to initiate treatment with one application per day, gradually increasing to two or three times daily as necessary or as directed by a healthcare professional, to minimize the risk of excessive skin dryness.

In cases where bothersome dryness or peeling occurs, the frequency of application should be reduced to once daily or every other day. After each application, the product must be rinsed off thoroughly.

For individuals using the product for the first time, it is advisable to apply it sparingly to one or two small affected areas during the initial three days. If no discomfort is experienced, the user may then proceed to follow the standard dosing instructions.

Contraindications

Use of this product is contraindicated in patients who experience irritation. In such cases, it is advised to limit the use to one topical acne medication at a time to prevent exacerbation of irritation. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients that the application of this product may lead to skin irritation and dryness, particularly if used concurrently with other topical acne medications. It is recommended that only one topical acne medication be utilized at a time to minimize the risk of irritation.

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

Side Effects

Patients using this product may experience skin irritation and dryness, particularly if another topical acne medication is used concurrently. It is advised that only one topical acne medication be utilized at a time to minimize the risk of irritation.

This product is intended for external use only. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately. Care should be taken to keep this product out of reach of children to prevent any potential harm.

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 alleviate symptoms. Monitoring for signs of skin irritation is essential when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Acne Control (cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely to ensure that the medication is kept out of reach to prevent accidental ingestion. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For pediatric patients experiencing bothersome dryness or peeling, it is recommended to reduce the frequency of application to once daily or every other day to mitigate these effects.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal impacts associated with its use in this population. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. 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 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 relation to the use of this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential risks associated with overdosage.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure appropriate interventions can be implemented swiftly.

In all cases of suspected overdosage, the involvement of poison control experts can provide valuable guidance on specific management strategies tailored to the individual situation.

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 compound in these areas.

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 in the event of accidental ingestion of the medication. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should inform patients about the potential for skin irritation and dryness associated with the use of this medication. Patients should be cautioned that the likelihood of these side effects increases if they are using another topical acne medication concurrently. Therefore, it is recommended that patients use only one topical acne medication at a time to minimize the risk of irritation.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should counsel patients on the potential for skin irritation and dryness, particularly when used concurrently with other topical acne medications. If irritation arises, it is advisable to limit the use to one topical acne treatment at a time. Should patients experience bothersome dryness or peeling, they should reduce the application frequency to once daily or every other day.

For new users, a sensitivity test is recommended: apply the product sparingly to one or two small affected areas for the first three days. If no discomfort is noted, patients may proceed with the full application as directed.

Drug Information (PDF)

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

View product document (PDF)