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Image Clear Cell Acne Spot Treatment

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Active ingredient
Salicylic Acid 20 g/1000 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
December 11, 2025
Active ingredient
Salicylic Acid 20 g/1000 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
December 11, 2025
Manufacturer
Swiss-American CDMO, LLC
Registration number
M006
NDC root
60232-5022

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

Drug Overview

This medication is used for the treatment of acne, a common skin condition that can cause pimples, blackheads, and other blemishes. While specific details about how it works are not provided, its primary purpose is to help clear up acne and improve the overall appearance of your skin. If you're struggling with acne, this treatment may be a helpful option to consider.

Uses

If you're dealing with acne, this medication can help you manage and treat your condition. Acne is a common skin issue that can affect people of all ages, and this treatment is specifically designed to reduce breakouts and improve the overall appearance of your skin. By targeting the factors that contribute to acne, it aims to provide you with clearer skin and boost your confidence.

Dosage and Administration

Before using this product, make sure to clean your skin thoroughly. You should apply a thin layer to the entire affected area one to three times a day. It’s best to start with just one application daily. If you find that you need more, you can gradually increase to two or three times a day, but only if your doctor advises it.

If you experience bothersome dryness or peeling, reduce your application to once a day or even every other day. If you’re using this product for the first time, it’s a good idea to perform a sensitivity test. Apply a small amount to one or two small affected areas for the first three days. If you don’t feel any discomfort, you can proceed with the regular application as mentioned.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or warnings regarding its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You may experience skin irritation while using this medication, which can include symptoms like redness, burning, itching, peeling, or swelling. This irritation is more likely to happen if you are using another topical acne treatment at the same time. If the irritation becomes severe, it’s important to stop using the product and consult a doctor.

Additionally, if the medication is swallowed, seek medical help immediately or contact a Poison Control Center.

Warnings and Precautions

This product is for external use only, so please avoid applying it to sensitive skin. If you are using other topical acne medications, be cautious, as this can increase the risk of skin irritation and dryness. If you experience any irritation, such as redness, burning, itching, peeling, or swelling, consider using the product less often or in a lower concentration. It's best to use only one topical acne treatment at a time.

To protect your skin, limit sun exposure and always apply sunscreen. Be careful to keep the product away from your eyes, lips, and mouth, as well as from hair and dyed fabrics, which may be bleached by the product. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. If irritation becomes severe, stop using the product and consult your doctor.

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 product has not been specifically evaluated for use during pregnancy, which means there is limited information on its safety for you and your developing baby. However, the insert does not mention any specific warnings or contraindications related to its use while pregnant. Additionally, there are no dosage modifications or special precautions indicated for pregnant individuals.

As always, it's important to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to know that the safety of this product during lactation has not been established. This means that caution should be exercised when considering its use while nursing.

Additionally, there is a possibility that the product may be excreted in breast milk, but the effects on your nursing infant are currently unknown. It's always best to consult with your healthcare provider before using any new medication or product while breastfeeding to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

Additional Information

No further information is available.

FAQ

What is this product used for?

This product is used for the treatment of acne.

How should I apply this product?

Clean the skin thoroughly before applying a thin layer to the affected area one to three times daily.

What should I do if I experience dryness or peeling?

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Is there a sensitivity test I should perform?

Yes, apply the product sparingly to one or two small affected areas during the first 3 days to test for sensitivity.

What should I do if I experience severe irritation?

If irritation becomes severe, stop use and ask a doctor.

Can I use this product if I have very sensitive skin?

No, do not use this product if you have very sensitive skin.

Is this product safe to use during pregnancy?

The product has not been evaluated for use during pregnancy, and no specific warnings are provided.

What about using this product while nursing?

The safety of this product during lactation has not been established, so caution should be exercised.

How should I store this product?

Store the product at room temperature.

What should I do if I accidentally swallow this product?

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

Packaging Info

Below are the non-prescription pack sizes of Image Clear Cell Acne Spot Treatment (salicylic acid acne gel). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Image Clear Cell Acne Spot Treatment.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the treatment of acne. It is intended for use in patients diagnosed with acne vulgaris, providing therapeutic benefits in managing this dermatological condition.

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, which may be done one to three times daily.

Initially, it is advised to start with one application per day. Based on the patient's response and as directed by a physician, the frequency may be gradually increased to two or three times daily. In cases where bothersome dryness or peeling occurs, the application frequency 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, the user may then proceed to follow the standard application instructions as outlined above.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with very sensitive skin. Caution is advised when using this product in conjunction with other topical acne medications, as the likelihood of skin irritation and dryness may increase. In the event of irritation, it is recommended to limit the use to one topical acne medication at a time.

Healthcare professionals should advise patients to avoid unnecessary sun exposure and to apply a broad-spectrum sunscreen to protect the skin. Direct contact with the eyes, lips, and mouth should be strictly avoided, as well as contact with hair and dyed fabrics, which may be susceptible to bleaching by this product.

Patients may experience skin irritation, which can manifest as redness, burning, itching, peeling, or swelling. If such irritation occurs, it may be alleviated by reducing the frequency of application or by using a lower concentration of the product. Should irritation escalate to a severe level, patients are instructed to discontinue use and consult a healthcare provider.

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

Side Effects

Skin irritation is a potential adverse reaction associated with the use of this medication. Patients may experience symptoms such as redness, burning, itching, peeling, or possibly swelling. The likelihood of experiencing irritation may increase if the patient concurrently uses another topical acne medication.

In cases where irritation becomes severe, it is advised that patients discontinue use and consult a healthcare professional for further guidance. Additionally, if the medication is ingested, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

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 Image Clear Cell Acne Spot Treatment (salicylic acid acne gel). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Image Clear Cell Acne Spot Treatment.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and specific dosing recommendations for children are not provided. Caution is advised when administering this medication to ensure it is not accessible to young children.

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 product has not been evaluated for use during pregnancy. Currently, there are no specific warnings or contraindications associated with the use of this product in pregnant patients. Additionally, no dosage modifications are recommended for individuals who are pregnant. The prescribing information does not indicate any special precautions regarding pregnancy. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential and pregnant patients about the use of this product.

Lactation

The safety of this product during lactation has not been established. Caution should be exercised when using this product in lactating mothers. There is a potential for excretion in breast milk, and the effects on breastfed infants are unknown.

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

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

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 at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Image Clear Cell Acne Spot Treatment, 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 Image Clear Cell Acne Spot Treatment, 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.

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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.