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Zitlox Salicylic Acne

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Active ingredient
Salicylic Acid 1.5 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
January 6, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Salicylic Acid 1.5 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
January 6, 2025
Manufacturer
ASA Universal Inc. dba: SONAGE
Registration number
M006
NDC root
69546-201
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

SONÄGE ZITLOX SALICYLIC ACNE GEL is a topical treatment designed to help clear acne blemishes and promote skin healing. It works by not only addressing existing acne but also preventing new blemishes from forming, making it a supportive option for those struggling with acne.

This gel is dermatologist and clinically tested, and it contains beneficial ingredients like postbiotic, tea tree, and eucalyptus, which can help soothe and improve the skin's condition. With a volume of 15 ml (0.5 fl. oz.), it is formulated to assist you in achieving clearer skin.

Uses

If you're dealing with acne, this treatment can help clear up blemishes and promote healing of your skin. Not only does it work to eliminate existing acne, but it also helps prevent new blemishes from forming, giving you a better chance at achieving clearer skin. With consistent use, you can see improvements in your complexion and overall skin health.

Dosage and Administration

Before using this product, make sure to clean the affected area of your skin thoroughly. Once your skin is clean, apply a thin layer of the product to the entire area that needs treatment. You can do this one to three times a day, depending on your needs and your doctor's advice.

To avoid excessive drying of your skin, it's best to start with just one application each day. If your skin tolerates it well, you can gradually increase the frequency to two or three times daily. However, if you notice any bothersome dryness or peeling, reduce your application to once a day or even every other day. This way, you can find the right balance for your skin while still getting the benefits of the treatment.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. While there are no listed contraindications, controlled substance classifications, or risks of abuse or dependence, you should take care if the medication is swallowed. In such a case, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please follow these guidelines closely.

Side Effects

When using this product, you may experience skin irritation and dryness, especially if you are using another topical acne medication at the same time. To minimize the risk of irritation, it’s best to use only one topical acne treatment at a time.

Remember, this product is for external use only. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This medication is for external use only, so be sure to apply it only to your skin. If you are using other topical acne treatments, be cautious, as combining them can increase the risk of skin irritation and dryness. If you experience irritation, it’s best to stop using all but one of the topical medications.

In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center. Your safety is important, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

The safety of this product during pregnancy has not been established, so it's important to be cautious. The use of salicylic acid, a common ingredient in some medications, is generally not recommended for pregnant individuals due to potential risks to the developing fetus. There may be a risk of teratogenic effects, which means it could cause developmental issues in the baby.

If you are pregnant or planning to become pregnant, it’s essential to consult your healthcare provider before using this product. They can help you understand the risks and determine the best course of action for your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

When using this medication on children, start with one application per day to avoid excessive drying of the skin. You can gradually increase to two or three times a day if necessary, but always follow your doctor's advice. If you notice any bothersome dryness or peeling, reduce the application to once a day or every other day.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that the standard dosage may be appropriate, but it’s always wise to consult with a healthcare provider. They can help ensure that the medication is safe and effective for your individual health needs, especially if you have other medical conditions or are taking other medications.

As you or your loved ones age, it’s important to stay informed and proactive about health decisions. Always discuss any concerns or questions with a healthcare professional to ensure the best care.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective. Always keep your doctor informed about your kidney health, as they may need to adjust your medications or monitor you more closely.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients like you.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can provide guidance based on your individual situation.

Drug Interactions

It's important to be cautious when using multiple acne treatments at once. If you use another topical acne medication alongside this one, you may experience increased skin irritation and dryness. To minimize these side effects, it's best to use only one topical acne medication at a time.

Always discuss your current medications and any new treatments with your healthcare provider. They can help you determine the safest and most effective approach for your skin care routine.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, covering the entire affected area with a thin layer. Start with one application daily, and if necessary, you can gradually increase to two or three times a day as directed by your doctor. If you experience bothersome dryness or peeling, reduce the application to once a day or every other day.

FAQ

What is SONÄGE ZITLOX SALICYLIC ACNE GEL used for?

SONÄGE ZITLOX SALICYLIC ACNE GEL clears acne blemishes, allows skin to heal, and helps prevent new acne blemishes from forming.

How should I apply SONÄGE ZITLOX SALICYLIC ACNE GEL?

Clean the skin thoroughly before applying a thin layer to the affected area one to three times daily. Start with one application daily and gradually increase if needed.

What should I do if I experience dryness or peeling?

If you experience bothersome dryness or peeling, reduce the application to once a day or every other day.

Is SONÄGE ZITLOX SALICYLIC ACNE GEL safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and the use of salicylic acid is generally contraindicated due to potential risks to the fetus.

What precautions should I take when using this product?

For external use only. Avoid using another topical acne medication at the same time to reduce the risk of skin irritation and dryness.

What should I do if I accidentally swallow SONÄGE ZITLOX SALICYLIC ACNE GEL?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store SONÄGE ZITLOX SALICYLIC ACNE GEL?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Zitlox Salicylic Acne.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

SONÄGE® ZITLOX SALICYLIC ACNE GEL is a dermatologist-tested and clinically tested formulation designed to clear acne blemishes. This gel incorporates postbiotics and natural ingredients, including tea tree and eucalyptus extracts. The product is presented in a 15 ml (0.5 fl. oz.) dosage form. It is distributed by Sonäge, located in Santa Monica, CA 90405, U.S.A. For more information, visit sonage.com.

Uses and Indications

This drug is indicated for the treatment of acne vulgaris. It effectively clears existing acne blemishes and promotes skin healing. Additionally, it helps prevent the formation of new acne blemishes, thereby contributing to the overall management of acne in affected individuals.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of this product. The recommended application involves covering the entire affected area with a thin layer. This can be done one to three times daily, depending on the patient's needs and the physician's guidance.

It is advisable to initiate treatment with one application per day to minimize the risk of excessive skin drying. Based on the patient's response, the frequency may be gradually increased to two or three times daily as necessary or as directed by a healthcare provider.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the frequency of application to once daily or every other day to alleviate these symptoms.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid concurrent use of this product with other topical acne medications, as this may increase the likelihood of skin irritation and dryness. In the event that irritation occurs, it is recommended that patients limit their use to one topical acne medication at a time to mitigate adverse effects.

In cases of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. It is crucial to ensure that patients are aware of these precautions to promote safe and effective use of the product.

Side Effects

Patients using this product should be aware that it is for external use only. The application of this medication may lead to skin irritation and dryness, particularly if used concurrently with another topical acne medication. In such cases, it is advised to limit the use to one topical acne treatment at a time to minimize the risk of irritation.

Additionally, it is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

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

Packaging configurations for Zitlox Salicylic Acne.
Details

Pediatric Use

Pediatric patients should be monitored closely when using this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For topical application, it is recommended to initiate treatment with one application daily to minimize the risk of excessive skin drying. Dosage may be gradually increased to two or three times daily as needed or directed by a healthcare professional. If patients experience bothersome dryness or peeling, the frequency of application should be reduced to once a day or every other day.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of this product during pregnancy has not been established. The use of salicylic acid during pregnancy is generally contraindicated due to potential risks to the fetus. There may be a risk of teratogenic effects associated with the use of salicylic acid in pregnant individuals. Therefore, pregnant women should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning 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

There is no information available 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 individual patient's liver status when prescribing this medication.

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 and emergency medical services is recommended to ensure optimal patient care and safety.

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 understanding of potential risks associated with the compound in nonclinical settings.

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 medication is swallowed. It is crucial for patients to understand the potential risks associated with accidental ingestion.

Additionally, healthcare providers should inform patients about the likelihood of skin irritation and dryness when using this medication in conjunction with other topical acne treatments. Patients should be counseled to use only one topical acne medication at a time to minimize the risk of irritation. This guidance is essential for ensuring the safe and effective use of the medication.

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 medication is administered topically, with a recommended application of a thin layer to the entire affected area one to three times daily. Clinicians should advise patients to start with one application per day, gradually increasing to two or three times daily as needed or directed by a healthcare provider. If patients experience bothersome dryness or peeling, they should reduce the frequency of application to once a day or every other day.

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

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Zitlox Salicylic Acne, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.