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Harris Teeter Anti-Itch Cooling Relief

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Gel
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 19, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Gel
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 19, 2017
Manufacturer
Harris Teeter
Registration number
part348
NDC root
72036-408
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

You may be looking for a treatment for skin irritation, inflammation, and rashes. This medication is designed to help relieve itching associated with these conditions. It can be used by adults and children aged 2 years and older, providing soothing relief when applied to the affected area.

For external anal and genital itching, it is recommended to clean the area gently before application. This medication can also be applied up to 3 to 4 times daily, but if you have a child under 12 years old, it's best to consult a doctor for guidance.

Uses

If you're dealing with itching caused by skin irritation, inflammation, or rashes, this medication can help provide relief. It's also effective for external anal and genital itching in adults, making it a useful option for those uncomfortable symptoms.

Rest assured, this medication has not been associated with teratogenic effects (which means it doesn't cause birth defects) or any other nonteratogenic effects. This makes it a safer choice for those concerned about potential 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 the medication. 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

It's important to use this medication safely. You should not apply it in the genital area if you have a vaginal discharge or use it for diaper rash; in these cases, please consult your doctor. Additionally, avoid contact with your eyes and do not exceed the recommended dosage unless directed by your healthcare provider. Never insert the medication directly into the rectum using your fingers or any device.

By following these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns, don't hesitate to reach out to your healthcare professional.

Side Effects

It's important to use this product only on the skin and not for any other purpose. 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 the product and consult a doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

Always remember to avoid using any other hydrocortisone products without first discussing it with your healthcare provider. Your health and safety are paramount, so don't hesitate to reach out to a doctor if you have any concerns.

Warnings and Precautions

This product is for external use only, so please avoid using it on 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.

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 come back within a few days. Additionally, if you experience any rectal bleeding, it’s important to seek medical advice right away. Remember, do not start using any other hydrocortisone product without consulting your doctor first.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

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, as this will help them provide the best care. Remember, it's always better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

When it comes to using hydrocortisone gel during pregnancy, there is currently no specific information available about its safety, dosage adjustments, 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 benefits and risks based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for 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 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 itching from skin irritation, inflammation, or rashes, 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 external anal and genital itching, adults should 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

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 be adjusted 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 condition. They can help monitor your kidney health and make any necessary changes 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment 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 provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

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

You will apply this medication topically, which means you will apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market.

FAQ

How should I use this medication for skin irritation, inflammation, and rashes?

For adults and children 2 years and older, apply to the affected area no more than 3 to 4 times daily. For children under 2 years, consult a doctor.

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

Clean the affected area with mild soap and warm water, then gently dry it. Apply to the affected area no more than 3 to 4 times daily. Children under 12 years should consult a doctor.

Are there any contraindications for using this medication?

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 or does not improve?

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 medication?

This medication is for external use only. Avoid contact with eyes and do not use more than directed unless advised by a doctor.

What should I do if I accidentally swallow this medication?

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

What is the recommended storage condition for this medication?

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

Packaging Info

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

Packaging configurations for Harris Teeter Anti-Itch Cooling Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the relief of itching associated with skin irritation, inflammation, and rashes. 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 application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. Patients should refrain from using any other hydrocortisone products unless directed by a healthcare provider. Additionally, if rectal bleeding occurs, patients must stop using the product and seek medical advice promptly.

Side Effects

Patients should be aware that the product is intended for external use only.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, or if rectal bleeding occurs. It is also recommended that patients refrain from using any other hydrocortisone products without prior consultation with a doctor.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Harris Teeter Anti-Itch Cooling Relief.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to affected areas for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a doctor 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 before application. For children under 12 years of age, it is recommended to seek medical advice before using the product.

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

The safety of hydrocortisone gel during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when considering the administration of hydrocortisone gel to pregnant patients.

Due to the lack of available safety data, it is recommended that the potential benefits be weighed against any possible risks to fetal outcomes. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to using hydrocortisone gel.

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

There are currently no specific details 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 absence of documented overdosage information, it is recommended that clinicians follow standard protocols for managing suspected overdose situations, which may include supportive care and symptomatic treatment.

In the event of an overdose, healthcare providers should assess the patient's clinical status and consider contacting a poison control center for guidance on management strategies. Continuous monitoring of vital signs and supportive measures may be necessary to ensure patient safety.

As further data becomes available, it is essential for healthcare professionals to remain informed and adhere to updated guidelines regarding the management of 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 these contexts.

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 to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this 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 stop using the product 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 cautioned against starting any other hydrocortisone product without first consulting a doctor.

Instruct patients to stop use and seek medical attention if rectal bleeding occurs. It is essential to remind patients to avoid contact with the eyes while using this product. Furthermore, patients should be advised not to exceed the directed dosage unless specifically instructed to do so by a doctor. Lastly, patients should be cautioned 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 for identification. It should be stored at room temperature, within the range of 20° to 25°C (68° to 77°F). For proper inventory management, 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, adherence to the recommended storage conditions is essential 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 Anti-Itch Cooling Relief, 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 Anti-Itch Cooling Relief, 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.