Resurfacing Acne Swipes

Description

Salicylic Acid 2.0% is the active ingredient. The formulation contains several inactive ingredients, including Water, Sodium Hydroxide, Lactic Acid, Glycolic Acid, Phytic Acid, Polysorbate 20, Propanediol, Glycerin, Carica Papaya (Papaya) Fruit Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Heterotheca Inuloides Flower Extract, Ricinus Communis (Castor) Seed Oil, Decyl Glucoside, Coco-Glucoside, Polyglyceryl-10 Caprylate/Caprate, Arbutin, Azelaic Acid, Dipotassium Glycyrrhizate, Gluconic Acid, Glutathione, Glyceryl Oleate, Kojic Acid, Maltodextrin, Niacinamide, Phenoxyethanol, Ethylhexylglycerin, and Sodium Benzoate.

Uses and Indications

This drug is indicated for the management of acne. It is effective in treating both new and existing acne, as well as addressing clogged pores and signs of aging. The formulation includes salicylic, glycolic, and lactic acids, which work synergistically to gently exfoliate the skin, even skin tone, and remove pore-clogging impurities. This combination of alpha and beta hydroxy acids not only treats and prevents acne but also clarifies the skin, visibly improves texture, and reduces the appearance of fine lines and wrinkles.

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

Dosage and Administration

After cleansing, healthcare professionals should instruct patients to use one (1) pad to sweep over the dry face, concentrating on acne-prone areas of the skin. The product may be applied up to two times daily or as tolerated by the patient's skin condition.

To minimize the risk of excessive drying, it is recommended that new users begin with one application daily. Patients may gradually increase the frequency to two or three times daily if necessary or as directed by a healthcare provider.

In cases where bothersome dryness or peeling occurs, patients should reduce the application frequency to once a day or every other day.

For new users, a sensitivity test is advised: apply the product sparingly to one or two small affected areas during the first three days. If no discomfort is experienced, patients may then proceed to follow the standard application instructions.

Contraindications

There are no contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if irritation becomes severe.

Warnings and Precautions

For external use only. The application of this product may lead to skin irritation and dryness, particularly when used concurrently with other topical acne medications. To minimize the risk of irritation, it is advised to use only one topical acne medication at a time.

In the event that irritation becomes severe, it is imperative to discontinue use and consult a healthcare professional for further guidance.

In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended without delay.

Side Effects

For external use only. Patients using this product may experience skin irritation and dryness, particularly if another topical acne medication is used concurrently. The likelihood of these adverse reactions increases with simultaneous use of multiple topical agents. In the event that irritation becomes severe, patients are advised to discontinue use and consult a healthcare professional.

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 Resurfacing Acne Swipes (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 of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

For topical application, the product may be used up to two times daily or as tolerated by the skin. Due to the potential for excessive drying, it is advisable to initiate treatment with one application daily. Dosage may be gradually increased to two or three times daily if necessary or as directed by a healthcare professional. Should bothersome dryness or peeling occur, the frequency of application should be reduced to once a day or every other day.

For new users, a sensitivity test is recommended. This involves applying the product sparingly to one or two small affected areas during the first three days. If no discomfort is experienced, patients may then follow the previously mentioned application guidelines.

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 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 are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to 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

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding 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.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control experts is recommended to guide treatment decisions and ensure optimal patient care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: skin irritation, dryness, and severe irritation when used in conjunction with other topical acne medications. These events were reported voluntarily or through surveillance programs.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the medication is swallowed. It is important for healthcare providers to emphasize the potential risks associated with ingestion and the need for prompt action.

Patients should also be informed that the likelihood of skin irritation and dryness may increase if they are using another topical acne medication concurrently. Healthcare providers should recommend that patients use only one topical acne medication at a time to minimize the risk of irritation.

In the event that patients experience severe irritation, they should be instructed to discontinue use of the medication and consult a healthcare professional for further guidance. This ensures that patients are aware of the importance of monitoring their skin's response to treatment and seeking help when necessary.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place to maintain its integrity and efficacy. Proper storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The product is administered topically and can be applied up to two times daily, or as tolerated by the skin. Clinicians should counsel patients regarding the potential for increased sun sensitivity due to the presence of alpha hydroxy acids (AHAs) in the formulation. Patients are advised to use sunscreen, wear protective clothing, and limit sun exposure while using the product and for one week following its use.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)