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Harris Teeter Maximum Strength Anti-Itch

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
April 17, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Ointment
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 2017
Label revision date
April 17, 2017
Manufacturer
Harris Teeter
Registration number
part348
NDC root
72036-406
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

This medication is used to relieve itching caused by skin irritation, as well as external anal and genital itching. It is suitable for adults and children aged 2 years and older, who can apply it to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a doctor before use.

When using this medication for external anal and genital itching, it is advised to clean the area with mild soap and warm water, then gently dry it before application. This helps ensure the medication can work effectively to soothe the discomfort.

Uses

You can use this medication to help relieve itching caused by skin irritation. It is also effective for alleviating external anal and genital itching in adults. This treatment is designed to provide you with comfort and relief from these specific types of itching.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

It seems that there are no specific dosage or administration details available for this medication. This means that you should consult your healthcare provider for personalized instructions on how to take or use it. They will provide you with the necessary information regarding the correct dosage, how to administer it, and how often you should do so. Always follow their guidance to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this product in the genital area if you have a vaginal discharge; it's important to consult a doctor in such cases. Additionally, do not use it for treating diaper rash without medical advice. Always keep the product away from your eyes, and follow the usage instructions carefully—do not exceed the recommended amount unless directed by a healthcare professional. Lastly, avoid inserting the product directly into the rectum using fingers or any devices. If you have any questions or concerns, please reach out to your doctor for guidance.

Side Effects

This product is intended for external use only. If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using it and consult a doctor. Additionally, if you experience rectal bleeding, it is important to seek medical advice immediately. Please avoid using any other hydrocortisone products without first discussing it with your healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately. If you have a vaginal discharge, do not use this product in the genital area without consulting a doctor. Additionally, it is not intended for treating diaper rash, so please speak with a healthcare professional if you need treatment for that.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Also, seek medical advice if you experience rectal bleeding. Always consult your doctor before using any other hydrocortisone product.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, you may be wondering about the use of hydrocortisone ointment. According to the information available, there are no specific warnings, precautions, or dosage changes required for using this ointment during pregnancy. Additionally, the insert does not indicate that the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any risks to the fetus.

While this information suggests that hydrocortisone ointment may be safe to use during pregnancy, it's always best to consult with your healthcare provider before starting any new medication. They can provide personalized advice based on your health and circumstances.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If your child is experiencing skin irritation or itching, you can apply the treatment to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using the product.

For issues related to external anal and genital itching, adults should first clean the area with mild soap and warm water, then gently dry it before applying the treatment. For children under 12 years old, you should also seek advice from a doctor before use. Always prioritize your child's safety and consult a healthcare professional if you have any concerns.

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. They can monitor for any potential side effects and make recommendations based on individual health status. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney 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 for the medication do not include special monitoring or safety considerations tailored for patients 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 situation. They can help you understand how your kidney health may affect your treatment plan.

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 based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°-25°C (68°-77°F). It's important to keep an eye on the lot number and expiration date, which you can find on the box or the crimp of the tube.

When handling the product, always do so with care to maintain its integrity and safety. Make sure to follow any additional instructions provided to ensure proper use.

Additional Information

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions or concerns about using this medication, it's best to consult your healthcare provider for personalized advice.

FAQ

What is this drug used for?

This drug is used for treating itching of skin irritation and external anal and genital itching in adults.

How should I apply this drug for skin irritation?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age should ask a doctor.

What are the instructions for using this drug for external anal and genital itching?

Clean the affected area with mild soap and warm water, gently dry it, and then apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age should ask a doctor.

Are there any contraindications for using this drug?

Do not use in the genital area if you have a vaginal discharge or for the treatment of diaper rash. Consult a doctor in these cases.

What should I do if my condition worsens?

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

What precautions should I take when using this drug?

Avoid contact with eyes, do not use more than directed unless told by a doctor, and do not put directly into the rectum using fingers or any device.

Is this drug safe to use during pregnancy?

There are no specific warnings or contraindications regarding the use of this product during pregnancy mentioned in the provided text.

Can nursing mothers use this drug?

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

What should I do if I accidentally swallow this drug?

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

How should I store this drug?

Store at room temperature between 20°-25°C (68°-77°F).

Packaging Info

Below are the non-prescription pack sizes of Harris Teeter Maximum Strength Anti-Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Harris Teeter Maximum Strength Anti-Itch.
Details

Drug Information (PDF)

This file contains official product information for Harris Teeter Maximum Strength Anti-Itch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the relief of itching associated with skin irritation. It is also indicated for the treatment of external anal and genital itching in adults.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

There is currently no specific dosage or administration information available for this medication. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for detailed instructions regarding the appropriate dosage, route, method, and frequency of administration. It is essential to consider individual patient factors and clinical judgment when determining the appropriate treatment regimen.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, direct insertion into the rectum using fingers, mechanical devices, or applicators is prohibited.

Warnings and Precautions

For external use only. It is imperative to adhere to the following warnings and precautions to ensure safe usage of the product.

General precautions must be observed. The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay. The product is not intended for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a doctor.

Healthcare professionals should instruct patients to discontinue use and seek medical advice 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. Patients should also be advised against using any other hydrocortisone products unless directed by a healthcare provider. Furthermore, if rectal bleeding occurs, patients must stop using the product and contact their doctor immediately.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center right away.

Side Effects

For external use only. Patients are advised to stop use 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, patients should not begin the use of any other hydrocortisone product without first consulting a doctor. Rectal bleeding is another serious condition that warrants immediate medical attention.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Harris Teeter Maximum Strength Anti-Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Harris Teeter Maximum Strength Anti-Itch.
Details

Pediatric Use

For the treatment of itching associated with skin irritation, the medication is indicated for use in adults and children aged 2 years and older, with a recommended application of no more than 3 to 4 times daily to the affected area. For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry the area before application. The same frequency of application, not exceeding 3 to 4 times daily, applies. For children under 12 years of age, it is recommended to seek medical advice before use.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Hydrocortisone ointment may be used during pregnancy as there are no specific warnings, precautions, or dosage modifications indicated in the prescribing information. The available data does not specify whether the product is contraindicated in pregnant patients or if there are any associated risks to fetal outcomes. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of hydrocortisone ointment in women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved in the overdose. Continuous assessment and supportive measures are critical in ensuring patient safety and optimizing outcomes.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients 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.

Patients should be informed not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to communicate that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Patients should be instructed 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. They should also be advised not to start using any other hydrocortisone product without first consulting a doctor.

It is crucial to inform patients to stop use and seek medical attention if they experience rectal bleeding. While using this product, patients should be cautioned to avoid contact with their eyes.

Healthcare providers should emphasize that patients must not exceed the recommended dosage unless directed by a doctor. Furthermore, patients should be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 20° to 25°C (68° to 77°F). For proper identification, the lot number and expiration date can be found on the box or the crimp of the tube. Special handling requirements are not specified; however, standard precautions should be observed to maintain product integrity.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Harris Teeter Maximum Strength Anti-Itch, 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 Harris Teeter Maximum Strength Anti-Itch, 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

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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.