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Aquanil Hc

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Active ingredient
Hydrocortisone 0.01 g/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
February 9, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.01 g/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Lotion
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 2026
Label revision date
February 9, 2026
Manufacturer
Person and Covey
Registration number
M017
NDC root
0096-0810
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Aquanil HC is a medication designed to provide temporary relief from minor skin irritations, inflammations, itching, and rashes. It is particularly useful for conditions caused by insect bites, eczema (a skin condition that causes inflammation and irritation), psoriasis (a chronic skin condition that leads to the rapid growth of skin cells), and reactions to soaps, detergents, cosmetics, jewelry, as well as exposure to poison oak and poison sumac.

This product can help soothe your skin and alleviate discomfort associated with these conditions. However, it's important to consult with a doctor for any other uses beyond the indicated purposes.

Uses

You can use this product for the temporary relief of minor skin irritations, inflammations, itching, and rashes. It is effective for issues caused by insect bites, eczema, psoriasis, and reactions to soaps, detergents, cosmetics, jewelry, as well as exposure to poison oak and poison sumac.

If you have other skin concerns, it's important to consult with your doctor before using this product. They can provide guidance and ensure that it's appropriate for your specific situation.

Dosage and Administration

Before using the medication, make sure to shake the bottle well. If you are an adult or have a child who is 2 years old or older, you can apply the medication to the affected area up to 2 to 4 times a day.

For children under 2 years of age, it’s important to consult with a doctor before using this medication, as there is no recommended dosage for this age group without professional guidance. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

It's important to be cautious when using this product. You should not use it for diaper rash; instead, consult your doctor for appropriate treatment. If you need to stop using this product, make sure to talk to your doctor before starting any other hydrocortisone product. This ensures your safety and helps you find the best care for your needs.

Side Effects

You should be aware that this product is for external use only and must not come into contact with your eyes. If it does, rinse your eyes thoroughly with water.

If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult a doctor. Additionally, do not use this product for diaper rash without first speaking to a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. If it does come into contact with your eyes, rinse them thoroughly with water. Keep this product out of the reach of children. If swallowed, seek medical help or contact the Poison Control Center immediately.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. It's important not to use this product for diaper rash without first consulting a doctor. Always prioritize your health and safety.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

When it comes to using AQUANIL HC (hydrocortisone lotion) during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor regarding any medications you may consider during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Aquanil HC for nursing mothers. The information available does not indicate any particular considerations or precautions you need to take while using this product during lactation (the period of breastfeeding). Always consult with your healthcare provider if you have any concerns or questions about medications while nursing.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area no more than 2 to 4 times a day. However, if your child is under 2 years old, it's important to consult a doctor for guidance, as there is no standard dosage for this age group.

Always keep this medication out of reach of children. If your child accidentally swallows it, seek medical help or contact the Poison Control Center immediately. Your child's safety is the top priority, so following these guidelines is essential.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no known interactions between this medication and other drugs or laboratory tests. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health needs and any other medications you might be using. Always feel free to ask questions and share your complete list of medications during your appointments.

Storage and Handling

To ensure the best performance and safety of your product, store it in a location that is not exposed to extreme temperatures. This means keeping it away from excessive heat or cold, which can affect its effectiveness.

When handling the product, always do so with care to maintain its integrity. If there are any specific components or instructions related to its use, be sure to follow those guidelines closely for optimal safety and performance.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 2 to 4 times a day. If the patient is under 2 years old, it's important to consult a doctor for guidance on dosage, as there is no standard recommendation for this age group.

FAQ

What is Aquanil HC used for?

Aquanil HC is used for the temporary relief of minor skin irritations, inflammations, itching, and rashes caused by conditions such as insect bites, eczema, and psoriasis.

How should I use Aquanil HC?

For adults and children 2 years of age and older, apply to the affected area not more than 2 to 4 times daily. For children under 2 years, use only under the advice and supervision of a doctor.

Are there any warnings associated with Aquanil HC?

Yes, Aquanil HC is for external use only. Avoid contact with eyes, and if contact occurs, rinse thoroughly with water.

What should I do if my condition worsens while using Aquanil HC?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Can I use Aquanil HC for diaper rash?

No, do not use Aquanil HC for diaper rash. Consult a doctor for appropriate treatment.

Is there any information about using Aquanil HC during pregnancy?

The insert does not provide specific information regarding the use of Aquanil HC during pregnancy.

What should I do if Aquanil HC is swallowed?

Keep Aquanil HC out of the reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

How should I store Aquanil HC?

Store Aquanil HC away from excessive heat or cold.

Packaging Info

Below are the non-prescription pack sizes of Aquanil Hc (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aquanil Hc.
Details

Drug Information (PDF)

This file contains official product information for Aquanil Hc, 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 temporary relief of minor skin irritations, inflammations, itching, and rashes caused by various conditions, including insect bites, eczema, psoriasis, soaps, detergents, cosmetics, jewelry, poison oak, and poison sumac.

Limitations of Use Other uses of this product should be undertaken only under the advice and supervision of a doctor.

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before use.

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 2 to 4 times daily.

In the case of children under 2 years of age, there is no recommended dosage unless advised and supervised by a physician.

Contraindications

The product is contraindicated for use in the following situations:

  • It should not be used for diaper rash; consultation with a healthcare professional is advised in such cases.

  • Discontinue use of this product and refrain from initiating any other hydrocortisone product without prior consultation with a healthcare provider.

Warnings and Precautions

This product is intended for external use only. It is imperative to avoid contact with the eyes; in the event of contact, the affected area should be rinsed thoroughly with water to mitigate any potential irritation.

To ensure safety, this product must be kept out of the reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following conditions occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is crucial that patients refrain from using any other hydrocortisone products without prior consultation with a healthcare provider.

Additionally, this product is not indicated for use in treating diaper rash; consultation with a physician is recommended in such cases.

Side Effects

Patients using this product should be aware of several important warnings and recommendations regarding adverse reactions. This product is intended for external use only and should not come into contact with the eyes. In the event of eye contact, it is advised to rinse thoroughly with water.

Patients are instructed to stop using the product and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, the product should not be used for diaper rash without prior consultation with a healthcare professional.

These precautions are essential to ensure the safe and effective use of the product, minimizing the risk of adverse reactions.

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 Aquanil Hc (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aquanil Hc.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area 2 to 4 times daily. For children under 2 years of age, no recommended dosage is provided unless directed by a physician.

It is essential to keep the medication out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of AQUANIL HC (hydrocortisone lotion) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider this lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or recommendations regarding the use of Aquanil HC in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of Aquanil HC in nursing mothers without specific concerns related to breastfeeding.

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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and adhere to standard protocols for managing potential overdose situations.

In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the individual case. It is essential to document any findings and interventions thoroughly to ensure continuity of care and facilitate further evaluation if required.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to keep this medication out of the reach of children. In the event of accidental ingestion, they should seek medical assistance or contact the Poison Control Center immediately.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should be cautioned against using any other hydrocortisone products without prior consultation with a healthcare professional.

Additionally, it is important to inform patients that this product is not intended for use on diaper rash, and they should seek medical advice if they have questions regarding its use in such cases.

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 controlled environment, away from excessive heat or cold, to maintain its integrity and efficacy. Proper storage conditions are crucial for ensuring the product remains effective throughout its shelf life.

Additional Clinical Information

For adults and children aged 2 years and older, the medication should be applied to the affected area no more than 2 to 4 times daily. In children under 2 years of age, no recommended dosage is provided, and administration should only occur under the advice and supervision of a healthcare professional.

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 Aquanil Hc, 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 Aquanil Hc, 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.