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Acne Calming Water Cream

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Active ingredient
Salicylic Acid 10 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
October 15, 2025
Active ingredient
Salicylic Acid 10 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
October 15, 2025
Manufacturer
e. l. f. Cosmetics, Inc.
Registration number
M006
NDC root
76354-416

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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, helping to prevent new acne blemishes from forming. It works by targeting the underlying causes of acne, making it an effective option for those looking to manage their skin condition. If you're struggling with acne, this treatment may be a helpful part of your skincare routine.

Uses

If you're dealing with acne, this medication can help treat your existing breakouts and also work to prevent new blemishes from forming. By targeting the causes of acne, it aims to clear your skin and reduce the likelihood of future outbreaks. This can be a valuable part of your skincare routine if you're looking to achieve a clearer complexion.

Dosage and Administration

Before you start using the medication, make sure to cleanse your skin thoroughly. Once your skin is clean, apply a thin layer of the medication to the entire affected area. You can do this one to three times a day, depending on what your doctor recommends or what feels best for you. It’s a good idea to start with just one application each day and then gradually increase to two or three times daily if needed.

If you notice any bothersome dryness or peeling, you should reduce your application to once a day or even every other day. If you’re new to this medication, it’s best to apply it sparingly to one or two small affected areas for the first three days. If you don’t experience any discomfort, you can then follow the regular application instructions provided.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. While there are no listed contraindications or concerns about abuse, misuse, or dependence (which means becoming reliant on the medication), you should take care when using it.

If you accidentally swallow the medication, seek medical help immediately or contact a Poison Control Center. Your safety is the top 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.

Please remember that this product is for external use only. If you accidentally swallow it, 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 the additional product and stick to just one topical acne medication at a time.

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 act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms. If you notice anything concerning, don’t hesitate to reach out for help. Remember, getting prompt assistance can make a significant difference in managing the situation effectively.

Pregnancy Use

It’s important to be cautious when considering the use of this product during pregnancy, as its safety has not been established. Salicylic acid, a key ingredient, is not recommended for use while pregnant due to potential risks to your developing baby.

If you are pregnant or planning to become pregnant, it’s essential to consult with your healthcare provider before using this product. They can provide guidance tailored to your specific situation and help ensure the safety of both you and 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 to prevent accidental ingestion. If a child swallows it, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

While there is no specific information about the use of Acne Calming Water Cream in older adults, it's always important to approach any new skincare product with caution. If you or a loved one is considering using this cream, it’s wise to consult with a healthcare provider, especially if there are existing health concerns or medications involved.

Since the drug insert does not mention any dosage adjustments or safety precautions for elderly patients, you should monitor for any unusual reactions when starting the product. Always prioritize gentle and safe skincare practices, particularly for sensitive skin that may be more common in older adults.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance tailored to your specific situation.

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 need 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 quality and safety of your product, store it at room temperature and keep it 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

When using this topical acne medication, be aware that combining it with other topical acne treatments can increase the risk of skin irritation and dryness. If you experience irritation, it's best to use only one topical acne product at a time. Should you notice bothersome dryness or peeling, consider reducing your application to once a day or every other day.

If you're trying this product for the first time, it's recommended to perform a sensitivity test. Apply a small amount to one or two small areas of your skin for the first three days. If you don't experience any discomfort, you can then follow the full usage instructions provided on the label.

FAQ

What is this product used for?

This product is used for the treatment of acne and helps prevent new acne blemishes.

How should I apply this medication?

Cleanse the skin thoroughly before applying a thin layer to the entire 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.

What precautions should I take when using this product?

For external use only. Skin irritation and dryness may occur if you use another topical acne medication at the same time.

What should I do if I swallow this product?

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

Is this product safe to use during pregnancy?

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

What should nursing mothers know about this product?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

How should I store this product?

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 Acne Calming Water Cream (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acne Calming Water Cream.
Details

Drug Information (PDF)

This file contains official product information for Acne Calming Water Cream, 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 specified drug.

Uses and Indications

This drug is indicated for the treatment of acne. It assists in preventing the formation of new acne blemishes.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleansed prior to the application of the medication. The medication should be applied as a thin layer to the entire affected area one to three times daily, depending on the patient's needs and the physician's recommendations.

For initial treatment, it is advisable to start with one application per day. The frequency may be gradually increased to two or three times daily as tolerated. In cases where bothersome dryness or peeling occurs, the application frequency should be reduced to once daily or every other day.

For patients who are new to the treatment, it is recommended to apply the product sparingly to one or two small affected areas during the first three days. If no discomfort is experienced, the patient may then proceed to follow the standard application instructions as indicated.

Contraindications

There are no contraindications listed for this product. However, it is imperative to seek medical assistance or contact a Poison Control Center immediately 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 risk 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 medication.

Side Effects

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

This product is intended for external use only. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 Acne Calming Water Cream (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acne Calming Water Cream.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of Acne Calming Water Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any concurrent medications of geriatric patients to ensure safe and effective use.

Pregnancy

The safety of this product during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risk to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use to discuss potential risks and benefits.

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 renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific recommendations are not provided in the current prescribing information.

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring 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.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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. If patients experience any signs of irritation, they should be instructed to discontinue use and consult their healthcare provider for further guidance.

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, ensuring that it is protected from light exposure. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients that the use of this product in conjunction with other topical acne medications may increase the likelihood of skin irritation and dryness. If patients experience bothersome dryness or peeling, they should reduce the frequency of application to once daily or every other day.

For new users, it is recommended to conduct a sensitivity test by applying 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 Calming Water Cream, 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 Acne Calming Water Cream, 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.