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Hexashield Anti Itch

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Active ingredient
Hydrocortisone 5 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
January 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 5 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
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 2021
Label revision date
January 1, 2025
Manufacturer
Tai Guk Pharm. Co. , Ltd.
Registration number
M017
NDC root
43136-203
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

HeXasheild is an anti-itch cream designed to provide temporary relief from itching associated with minor skin irritations, inflammation, and rashes. It contains 0.5% hydrocortisone, a medication that helps reduce inflammation and soothe the skin. This cream can be used for various conditions, including eczema, psoriasis, insect bites, and reactions to plants like poison ivy, as well as irritations caused by detergents, jewelry, cosmetics, and soaps.

In addition to its primary uses, HeXasheild can also temporarily relieve external anal and genital itching. It is fragrance-free and includes soothing aloe to enhance its calming effects on the skin. For any other uses, it is recommended to consult with a doctor for guidance.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions like eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It’s also effective for soothing itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it can help relieve external anal and genital itching.

For any other uses, it's important to consult with your doctor to ensure safety and effectiveness.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day. This is suitable for adults and children who are 2 years old and older. However, if your child is under 2 years of age, it's best to consult a doctor before use.

For external itching around the anal and genital areas in adults, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. After cleaning, pat the area dry with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person is under 12 years old, please consult a doctor for guidance.

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—please consult your doctor in these cases. Additionally, make sure to follow the dosage instructions carefully; do not use more than directed unless your doctor advises otherwise. Avoid inserting the medication directly into the rectum using your fingers or any device, as this can lead to complications. Always prioritize your health and seek guidance from a healthcare professional if you have any questions or concerns.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid contact with your eyes and not use it more than directed unless your doctor advises otherwise. If you notice that your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult your doctor. Additionally, do not use it in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a doctor first.

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

Warnings and Precautions

This product is for external use only, so please avoid using it on internal areas, especially if you have a vaginal discharge or are treating diaper rash—consult your doctor in these cases.

If your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and talk to your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

In case of accidental swallowing, it’s important to get emergency medical help or contact a Poison Control Center right away. Always prioritize your health and safety by following these guidelines.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the specific situation.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek medical help right away. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

When considering the use of HeXashield Anti Itch Cream with Healing Aloe (hydrocortisone cream) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this cream on you or your developing baby are not well-studied or documented.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including over-the-counter creams. They can help you weigh the potential benefits and risks based on your individual situation.

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 first clean the area with mild soap and warm water, then gently dry it before applying the treatment. If your child is under 12 years old, please ask a doctor for guidance 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 outcomes.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to 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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. Always check the Lot Number and Expiration Date, which you can find on the box or the crimp of the tube, to ensure you are using a valid and safe product.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area. For adults and children aged 2 years and older, use it no more than 3 to 4 times a day. If the patient is under 2 years old or if the child is under 12 years old, it's important to consult a doctor before use. For external anal and genital itching, adults can also apply it to the affected area up to 3 to 4 times daily. Always follow your healthcare provider's guidance for the best results.

FAQ

What is HeXasheild?

HeXasheild is an anti-itch cream that contains 0.5% hydrocortisone and soothing aloe, designed to relieve skin irritation and rashes.

What conditions can HeXasheild help with?

HeXasheild provides temporary relief for itching associated with minor skin irritations, including eczema, psoriasis, insect bites, and rashes from poison ivy, detergents, and more.

How should I use HeXasheild?

For adults and children 2 years and older, apply to the affected area 3 to 4 times daily. For children under 2, consult a doctor.

Are there any warnings when using HeXasheild?

Yes, avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum. Consult a doctor if you have a vaginal discharge or are treating diaper rash.

What should I do if my condition worsens?

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

Is HeXasheild safe to use during pregnancy or while nursing?

There is no specific information regarding the use of HeXasheild during pregnancy or lactation, so consult a doctor before use.

What should I do if I accidentally swallow HeXasheild?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Where is HeXasheild made?

HeXasheild is made in Korea and distributed by LG Household & Health Care Ltd.

Packaging Info

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

Packaging configurations for Hexashield Anti Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

HeXasheild is an anti-itch cream formulated with 0.5% hydrocortisone, designed for regular strength application. This cream is specifically developed for sensitive skin and is enhanced with soothing aloe to provide additional healing properties. The product is fragrance-free, ensuring minimal irritation for users. HeXasheild is packaged in a net weight of 2 oz (57 g) and is distributed by LG Household & Health Care Ltd., located at 58, Saemunan-ro, Jongno-gu, Seoul, Korea. The cream is manufactured in Korea.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, psoriasis, poison ivy, oak, or sumac exposure, insect bites, and reactions to detergents, jewelry, cosmetics, and soaps. Additionally, it provides temporary relief for external anal and genital itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The medication should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is also recommended before use.

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.

Furthermore, the product should not be used in excess of the directed dosage unless specifically instructed by a physician. Direct application into the rectum using fingers, mechanical devices, or applicators is also contraindicated.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area if there is a vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a healthcare provider.

Patients should be instructed to discontinue use and seek medical advice 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 important to note that patients should not initiate the use of any other hydrocortisone product without consulting a healthcare professional. Immediate medical attention is required if rectal bleeding occurs.

In the event of accidental ingestion, patients should seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. Furthermore, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue 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. It is also crucial to seek medical attention if rectal bleeding occurs.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Hexashield Anti Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hexashield Anti Itch.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the medication for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not more than 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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no information available regarding the use of HeXashield Anti Itch Cream with Healing Aloe (hydrocortisone cream) during pregnancy. Consequently, the safety of this medication in pregnant patients has not been established, and there are no specific dosage modifications or special precautions recommended for use in this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this product in women of childbearing potential.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 question.

Postmarketing Experience

No postmarketing experience details are available for HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE (hydrocortisone cream). As such, there are no additional adverse events or rare case reports to report from voluntary or surveillance programs.

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 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 emphasize that the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

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 advised not to begin the use of any other hydrocortisone product unless directed by a doctor.

If rectal bleeding occurs, patients should stop using the product and seek medical advice. While using this product, patients must avoid contact with their eyes to prevent irritation.

Healthcare providers should remind patients not to exceed the directed dosage unless specifically instructed to do so by a doctor. Furthermore, 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 package configurations, with specific Lot Numbers and Expiration Dates indicated on the box or the crimp of the tube.

It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

The medication is administered topically, with specific guidelines for different age groups. Adults and children aged 2 years and older should apply the treatment to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised before use. In cases of external anal and genital itching, adults are also instructed to apply the medication to the affected area no more than 3 to 4 times daily, while children under 12 years of age should seek medical advice prior to application.

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

Drug Information (PDF)

This file contains official product information for Hexashield 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 Hexashield 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.

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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.