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Equaline 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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
November 15, 2024
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
November 15, 2024
Manufacturer
United Natural Foods, Inc. dba UNFI
Registration number
M017
NDC root
41163-973
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

EQUALINE is a maximum strength anti-itch cream that contains 1% hydrocortisone, a well-known ingredient recommended by doctors for fast relief from itching. This cream is enriched with aloe and vitamins A and E, along with 10 moisturizers, making it effective for soothing minor skin irritations, inflammation, and rashes caused by conditions such as eczema, psoriasis, and insect bites, as well as reactions to detergents, jewelry, cosmetics, and soaps.

You can use EQUALINE to temporarily relieve itching associated with these skin issues, including external anal and genital itching. It’s important to follow your doctor’s advice for any other uses of this product.

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, psoriasis, and reactions to poison ivy, oak, or sumac. It can also help soothe itching from insect bites, as well as irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can temporarily relieve itching in external anal and genital areas. For any other uses, it's important to consult with your doctor for advice and supervision.

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 if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using this treatment.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting it 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 needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a doctor first. While using this product, make sure to keep it away from your eyes and follow the dosage instructions carefully—do not exceed the recommended amount unless your doctor advises you to do so. Additionally, avoid inserting the product directly into the rectum using your fingers or any devices.

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 provider.

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, rectal bleeding, or if your condition persists for more than 7 days, stop using the product and consult a doctor. Additionally, do not use it in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a healthcare professional.

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 the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. While using this product, be careful not to get it in your eyes, and do not exceed the recommended dosage unless directed by your doctor. It's important not to insert it directly into the rectum using fingers or any devices.

You should stop using the product and contact your doctor if your condition worsens, if you experience rectal bleeding, or if your symptoms last more than 7 days or return after clearing up. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you are unsure. Remember, timely action can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or warnings regarding the use of this product during pregnancy. The information available does not mention any safety concerns, contraindications, or special precautions for using hydrocortisone cream while pregnant. Additionally, there are no recommended dosage modifications for pregnant individuals.

While the absence of specific information may suggest that the product is generally considered safe, it's always best to consult with your healthcare provider before using any medication during pregnancy to ensure it is appropriate for 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 particular considerations or precautions noted about lactation or the possibility of the product being passed into breast milk. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your nursing infant.

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

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 monitor your kidney function 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 may affect you 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 a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

You can use this medication topically to relieve itching caused by skin irritation, inflammation, and rashes. For adults and children aged 2 years and older, apply it to the affected area no more than 3 to 4 times a day. If you're treating external anal and genital itching, it's best to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication, also no more than 3 to 4 times daily.

FAQ

What is EQUALINE?

EQUALINE is a maximum strength anti-itch cream that contains 1% hydrocortisone, enriched with aloe, vitamins A & E, and 10 moisturizers.

What conditions does EQUALINE relieve?

EQUALINE temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, insect bites, and more.

How should I use EQUALINE?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For external anal and genital itching, clean the area first and then apply.

Are there any warnings for using EQUALINE?

Yes, avoid contact with the eyes, do not use more than directed, and do not apply directly into the rectum. If symptoms worsen or persist for more than 7 days, consult a doctor.

Can I use EQUALINE if I am pregnant or nursing?

The insert does not provide specific information regarding the use of EQUALINE during pregnancy or lactation, so consult your doctor for advice.

What should I do if I accidentally swallow EQUALINE?

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

What should I avoid while using EQUALINE?

Do not use EQUALINE in the genital area if you have a vaginal discharge or for diaper rash. Always consult a doctor for these conditions.

Packaging Info

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

Packaging configurations for Equaline Anti Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

EQUALINE® is a maximum strength anti-itch cream formulated with 1% hydrocortisone, the #1 doctor-recommended active ingredient for itch relief. This cream is designed to provide fast relief from itching associated with dry skin, skin irritation, rashes, eczema, and psoriasis. EQUALINE® is enriched with aloe and vitamins A and E, along with 10 additional moisturizers to enhance skin hydration. The product is presented in a net weight of 1 ounce (28 grams).

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, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. 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, 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 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 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, it is recommended to consult a healthcare professional before use.

Contraindications

Use of this product is contraindicated in the following situations:

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

While using this product, it is essential to avoid contact with the eyes. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, the product must not be administered directly into the rectum using fingers, mechanical devices, or applicators.

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 medical advice.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed by a healthcare provider. Direct application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Patients should discontinue use and seek medical advice if any of the following occur: worsening of the condition, rectal bleeding, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, the use of any other hydrocortisone product should not commence without consulting a healthcare professional.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 advice.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage, refraining from using more than directed unless instructed by a healthcare professional. It is important not to apply the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical attention if any of the following occur: worsening of the condition, rectal bleeding, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, patients should not resume use of any other hydrocortisone product without consulting a doctor.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Equaline Anti Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Equaline 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, the use of this medication is not advised; consultation with a doctor is recommended.

In cases of external anal and genital itching, the same application frequency applies for adults. It is advised that the affected area be cleaned 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. For children under 12 years of age, it is recommended to 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.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions associated with the use of hydrocortisone cream in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. Given the absence of specific guidelines or warnings, healthcare professionals should consider the overall clinical context when prescribing this product to 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 specific considerations or precautions mentioned regarding lactation or the potential for excretion in breast milk.

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 individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. These include instances of skin irritation, rashes, and exacerbations of eczema and psoriasis. Additionally, reports indicate occurrences of rectal bleeding. It has been noted that some symptoms may persist for more than seven days or may resolve only to recur within a few days. Patients are advised not to initiate the use of any other hydrocortisone product without consulting a healthcare professional.

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 clarify that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have questions regarding its use in this context.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens or if rectal bleeding occurs. They should also be advised to seek medical attention if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days. Patients should not begin the use of any other hydrocortisone product without first consulting a doctor.

While using this product, patients should be cautioned to avoid contact with the eyes. They should also be reminded not to exceed the directed dosage unless specifically instructed to do so by a healthcare professional. 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 package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered topically for the treatment of itching associated with skin irritation, inflammation, and rashes in patients aged 2 years and older. It should be applied to the affected area no more than 3 to 4 times daily. For external anal and genital itching in adults, it is recommended to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application, also not exceeding 3 to 4 times daily.

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 Equaline 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 Equaline 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.