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Good Sense Anti Itch

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2006
Label revision date
September 29, 2024
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2006
Label revision date
September 29, 2024
Manufacturer
L. Perrigo Company
Registration number
M017
NDC root
0113-0541

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Drug Overview

GOODSENSE® is a maximum strength anti-itch cream designed to provide rapid relief from itching and redness. It contains 1% hydrocortisone, which is the active ingredient that helps alleviate discomfort associated with minor skin irritations, inflammation, and rashes. This cream is effective for various conditions, including eczema, insect bites, poison ivy, and even itching in sensitive areas.

In addition to relieving itching, GOODSENSE® helps improve the overall appearance of your skin by addressing issues like redness, dryness, flaking, and cracking. It is a doctor-recommended option for temporary relief, making it a supportive choice for managing skin irritations.

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 such as eczema, insect bites, and reactions to poison ivy, oak, or sumac. It can also help with irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. Additionally, it offers temporary relief for 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 important to consult a doctor before use.

For external anal and genital itching in adults, start by gently cleansing the area with mild soap and warm water, then rinse thoroughly. After that, pat or blot 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, it's best to ask a doctor for advice before using 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 without consulting a doctor. Additionally, avoid using this product if you experience rectal bleeding, and do not exceed the recommended dosage unless directed by your doctor. If your condition worsens, symptoms last longer than 7 days, or improve and then return within a few days, please consult your doctor before continuing use.

Always remember, do not insert this medication directly into the rectum using your fingers or any device. Your health and safety are paramount, so when in doubt, reach out to your healthcare provider for guidance.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If you experience worsening symptoms, if your condition does not improve after 7 days, or if you notice rectal bleeding, stop using the product and consult a doctor. Additionally, this product is for external use only and should not be applied in the genital area if you have a vaginal discharge or used for diaper rash without consulting a doctor.

If the product is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Always prioritize your health and safety by following these guidelines.

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 diaper rash—consult your doctor in these cases. When applying, be careful not to get it in your eyes, and only use the amount directed by your doctor. Do not insert it into the rectum using fingers or any devices.

If your condition worsens, symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately. If the product is swallowed, get emergency help or contact a Poison Control Center right away at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on what to look for are not provided here. Always err on the side of caution and reach out for help if you suspect an overdose has occurred. Your safety is the top priority, so don’t hesitate to get assistance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to avoid using this product. The potential risks during pregnancy are significant, and it is best to consult your doctor before considering its use. Your healthcare provider can help you understand any possible effects and guide you on safe options for your health and the health of 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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. This means that, based on current knowledge, you can use this product without concern for 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. This can also be done up to 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance before use.

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 wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and overall treatment goals. Always prioritize open communication with your healthcare team to ensure safe and effective use of any medication.

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 you have 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 health situation. They can help determine the best course of action based on your kidney function and overall health.

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).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You should apply this medication topically to the affected area, no more than 3 to 4 times a day. If you're treating external anal or genital itching, it's best to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting or blotting with toilet tissue or a soft cloth before applying the medication.

If the patient is a child under 2 years old, do not use this medication without consulting a doctor. For children under 12 years, it's also advisable to ask a doctor before use.

FAQ

What is GOODSENSE®?

GOODSENSE® is a maximum strength anti-itch cream that contains 1% hydrocortisone as its active ingredient.

What conditions does GOODSENSE® help relieve?

It temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I use GOODSENSE®?

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

Are there any warnings for using GOODSENSE®?

Yes, avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum.

What should I do if my condition worsens?

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

Can I use GOODSENSE® during pregnancy?

You should not use GOODSENSE® during pregnancy without consulting a doctor.

Is GOODSENSE® safe for nursing mothers?

There are no specific warnings regarding the use of GOODSENSE® by nursing mothers, but consult a doctor if you have concerns.

What should I do if I accidentally swallow GOODSENSE®?

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

Is GOODSENSE® paraben-free?

Yes, GOODSENSE® is paraben-free.

What is the net weight of GOODSENSE®?

The net weight of GOODSENSE® is 1 OZ (28 g).

Packaging Info

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

Packaging configurations for Good Sense Anti Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

GOODSENSE® Maximum Strength is an anti-itch cream formulated with 1% hydrocortisone, the #1 doctor-recommended active ingredient for itch relief. This cream is designed to provide rapid relief from itching associated with various skin conditions, including eczema, psoriasis, insect bites, seborrheic dermatitis, rashes, and reactions to poison ivy, oak, or sumac. It effectively addresses symptoms such as redness, dryness, flaking, scaling, and cracking, helping the skin to appear visibly healthier. The product is paraben-free and is available in a net weight of 1 oz (28 g).

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, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. 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 following dosage guidelines are recommended:

Adults and children aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a healthcare professional is advised.

In cases of external anal and genital itching in adults, it is advisable to first cleanse 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 prior to application. 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 healthcare professional is recommended before use.

Contraindications

Use is contraindicated in the following situations:

  • Application in the genital area is not recommended in patients with vaginal discharge; medical consultation is advised.

  • The product should not be used for the treatment of diaper rash; consultation with a healthcare professional is necessary.

  • Patients should refrain from using this or any hydrocortisone product if the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, unless directed by a physician.

  • Use is contraindicated in the presence of rectal bleeding.

  • Patients should not exceed the recommended dosage unless instructed by a healthcare provider.

  • Direct application into the rectum using fingers or any mechanical device or applicator is prohibited.

Warnings and Precautions

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

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and refrain from exceeding the directed amount unless specifically instructed by a healthcare provider. It is also crucial to avoid inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients should 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. Furthermore, this product, along with any other hydrocortisone products, should not be used without consulting a doctor under these circumstances. Immediate medical attention is required if rectal bleeding occurs.

In the event of accidental ingestion, it is essential to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 medical consultation.

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 healthcare professional. The product should not be administered 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. Furthermore, if rectal bleeding occurs, medical advice should be sought immediately.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 Good Sense Anti Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Good Sense Anti Itch.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product 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, the product should not be used without consulting a doctor.

For external anal and genital itching, the product is indicated for adults. It is advised that the affected area be cleansed with mild soap and warm water, rinsed thoroughly, and gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. The same frequency of application, not more than 3 to 4 times daily, applies. Children under 12 years of age should consult a doctor before use.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should not use this product due to potential risks. It is essential for women who are pregnant or planning to become pregnant to consult a healthcare professional prior to using this product. The safety of this medication during pregnancy has not been established, and its use may pose risks to fetal outcomes. Therefore, appropriate medical guidance is crucial for managing treatment options in this population.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective recovery.

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

Postmarketing experience has revealed reports of various adverse reactions associated with the use of the product. These include skin irritation, allergic reactions such as rash and urticaria, and contact dermatitis. Additionally, cases of hypopigmentation and secondary infections have been documented. There have also been reports of systemic effects with prolonged use, including adrenal suppression. Furthermore, other unspecified adverse reactions have been reported.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to inform patients that the product should not be used in the genital area if they have a vaginal discharge and that they should consult a doctor in such cases. Additionally, patients should be cautioned against using the product for the treatment of diaper rash and should seek medical advice if they are considering its use for this purpose.

Patients must 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 use this or any other hydrocortisone product without first consulting a doctor. Furthermore, patients should be made aware that they need to stop use and seek medical attention if rectal bleeding occurs.

When using the product, patients should be reminded to avoid contact with the eyes. It is essential to emphasize that they should not exceed the recommended dosage unless directed 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 package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being no more than 3 to 4 times daily to the affected area. For external anal and genital itching in adults, it is advised to cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry before application. The use of this medication is not recommended for children under 2 years of age, and those under 12 years should consult a doctor prior to use.

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

Drug Information (PDF)

This file contains official product information for Good Sense 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 Good Sense 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.