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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 1995
Label revision date
November 29, 2025
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 1995
Label revision date
November 29, 2025
Manufacturer
Person and Covey
Registration number
M017
NDC root
0096-0732
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 effective 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 plants like poison oak and poison sumac.

This product works by soothing the affected areas of your skin, helping to alleviate discomfort and promote healing. While it can be beneficial for these specific skin issues, it's important to consult with a doctor for any other uses.

Uses

This product is designed to provide temporary relief from minor skin irritations, inflammations, itching, and rashes. You can use it for issues caused by various factors, including insect bites, eczema, psoriasis, soaps, detergents, cosmetics, jewelry, and exposure to poison oak or poison sumac.

If you have other uses in mind, it's important to consult with your doctor for advice and supervision before proceeding.

Dosage and Administration

Before using this 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 aware of specific instructions regarding the use of this medication. You should not use it for diaper rash; if you have any concerns or questions about its use in this context, please consult your doctor for guidance.

Currently, there are no specified contraindications, risks of abuse or misuse, or dependence issues associated with this medication. Always prioritize your health and safety by following these guidelines.

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. Additionally, do not use this product for diaper rash without first consulting a doctor.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When it comes to using AQUANIL HC (hydrocortisone lotion) during pregnancy, there is currently no specific 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. Additionally, the information provided does not mention any particular considerations or precautions related to lactation. This means that, based on the available data, you can use Aquanil HC without concern for its effects on your milk production or your nursing infant.

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 the 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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 is safe and effective, especially if you have concerns about your kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or health tests.

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 included with the product, make sure to follow any additional instructions provided for their use or safety. Proper storage and handling are key to ensuring that the product remains safe and effective for your needs.

Additional Information

You should apply this medication topically to the affected area, using it no more than 2 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor for guidance on dosage. Always follow your healthcare provider's instructions for the best results.

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, consult a doctor for dosage.

Are there any warnings associated with Aquanil HC?

Yes, it is for external use only and should not get into your eyes. 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 instead.

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.

Are there any contraindications for Aquanil HC?

No specific contraindications are mentioned in the provided text.

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 specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor skin irritations, inflammations, itching, and rashes associated with various conditions, including insect bites, eczema, psoriasis, and reactions to soaps, detergents, cosmetics, jewelry, poison oak, and poison sumac.

Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised 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.

For children under 2 years of age, there is no recommended dosage unless prescribed by a physician, who should provide appropriate advice and supervision.

Contraindications

The product is contraindicated for use in the treatment of diaper rash. Consultation with a healthcare professional is advised for appropriate management in such cases. No other contraindications have been specified in the available data.

Warnings and Precautions

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.

General precautions must be observed to ensure safety. This product should 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 doctor if any of the following conditions arise: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is crucial to refrain from using this product for diaper rash and to seek medical advice in such cases. Additionally, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

Side Effects

Patients using this product may experience adverse reactions that necessitate caution and monitoring. The product is intended for external use only, and it is imperative to avoid contact with the eyes. In the event of eye contact, patients should rinse thoroughly with water.

Patients are advised to discontinue use and consult a doctor if any of the following occur: the condition worsens, 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 the use of 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 exists unless prescribed by a healthcare professional.

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 efficacy, 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. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this medication in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

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 clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has revealed several adverse reactions reported voluntarily or through surveillance programs. These include skin irritation, allergic reactions, and contact dermatitis. Additionally, cases of hypopigmentation and secondary infections have been noted. There have also been reports of systemic effects associated with prolonged use or application over large areas of the body.

Patient Counseling

Patients should be advised to keep this product 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 resolve 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 that 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 to ensure the product remains within the recommended temperature range, thereby safeguarding its quality and performance.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 2 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, no specific dosage is advised unless directed by a physician.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.