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Anti-Itch

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
June 19, 2018
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2013
Label revision date
June 19, 2018
Manufacturer
Product Quest Mfg
Registration number
part348
NDC root
64048-5113

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Drug Overview

This medication is designed to provide temporary relief from itching caused by minor skin irritations and rashes. It can be helpful for various conditions, including eczema, reactions to poison ivy, oak, and sumac, as well as irritations from cosmetics, jewelry, soaps, detergents, and insect bites.

While it is effective for these common skin issues, it's important to use this product under the guidance of a doctor for any other uses.

Uses

You can use this product for the temporary relief of itching caused by minor skin irritations and rashes. This includes conditions like eczema, reactions to poison ivy, oak, and sumac, as well as irritations from cosmetics, jewelry, soaps, detergents, and insect bites.

If you have other skin issues, it's best to consult with your doctor before using this product.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware that this product is for external use only and is flammable, so keep it away from fire or flames. Avoid getting it in your eyes. If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and consult a doctor before using any other hydrocortisone products. It is not intended for treating diaper rash, and you should also avoid puncturing or incinerating the container, as it is under pressure and should not be stored above 120°F.

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 applying it to any internal areas. It is flammable, so keep it away from fire or flames. Be careful not to let it come into contact with your eyes. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor before trying any other hydrocortisone products.

Do not use this product for diaper rash; instead, speak with your doctor for appropriate treatment. Remember, the contents are under pressure, so do not puncture or incinerate the container, and avoid storing it at temperatures above 120°F. If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Your safety is the top priority, so acting quickly can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or precautions regarding the use of hydrocortisone 1% spray during pregnancy mentioned in the available information. Additionally, the product insert does not indicate that it is contraindicated (not recommended) for use during pregnancy, nor does it highlight any risks to the fetus associated with its use.

However, as with any medication, it's always best to consult with your healthcare provider before using hydrocortisone 1% spray or any other treatment during pregnancy. They can provide personalized advice based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is highly recommended. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. Since elderly patients may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, even in the absence of specific guidelines, your healthcare provider is the best resource for ensuring safe and effective treatment tailored to the unique needs of older adults.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can provide guidance tailored to your needs, especially if you have concerns about your kidneys.

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 or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place where temperatures do not exceed 120°F (49°C). It's important to keep it away from fire or flames, as the contents are under pressure and can be dangerous if punctured or incinerated.

Always handle the product with care, and make sure to keep it out of reach of children to prevent any accidents. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of itching associated with minor skin irritation and rashes.

What conditions can this drug help relieve itching for?

It can help relieve itching due to eczema, poison ivy, oak and sumac, cosmetics, jewelry, soaps and detergents, and insect bites.

How should adults and children 2 years of age and older use this drug?

Apply to the affected area not more than 3 to 4 times daily.

Can children under 2 years of age use this drug?

No, do not use this drug for children under 2 years of age; consult a doctor instead.

Are there any warnings associated with this drug?

Yes, it is for external use only, flammable, and should be kept away from fire or flame. Avoid contact with eyes and consult a doctor if symptoms persist.

What should I do if this drug is swallowed?

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

Is this drug safe to use during pregnancy?

The insert does not indicate any contraindications in pregnancy, but you should consult a doctor for advice.

What about nursing mothers?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

Are there any specific storage instructions for this drug?

Yes, do not store at temperatures above 120˚F, keep away from fire or flame, and do not puncture or incinerate.

Packaging Info

Below are the non-prescription pack sizes of Anti-Itch (hydrocortisone 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Anti-Itch.
Details

Drug Information (PDF)

This file contains official product information for Anti-Itch, 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 data.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritation and rashes due to various conditions, including eczema, poison ivy, oak, and sumac exposure, as well as reactions to cosmetics, jewelry, soaps, detergents, and insect bites.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should be kept away from fire or flame to prevent any risk of ignition.

Healthcare professionals should advise patients to avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use of this product. It is imperative that patients do not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

This product is not indicated for the treatment of diaper rash. Patients should be instructed to consult a doctor for appropriate treatment options in such cases.

Additionally, it is crucial to inform patients that the container should not be punctured or incinerated, as it is under pressure. Storage should be maintained at temperatures not exceeding 120˚F to ensure safety and efficacy.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from fire or flame. Contact with the eyes should be avoided. If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a doctor before using any other hydrocortisone product.

This product is not recommended for the treatment of diaper rash, and consultation with a healthcare professional is necessary in such cases. Additionally, patients should not puncture or incinerate the container, as it is under pressure. It is crucial to store the product at temperatures not exceeding 120˚F.

Furthermore, 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 is recommended.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Anti-Itch (hydrocortisone 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Anti-Itch.
Details

Pediatric Use

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

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

Pregnancy

There are no specific warnings or precautions regarding the use of hydrocortisone 1% spray during pregnancy. The available data does not indicate whether the product is contraindicated in pregnancy or if there are any associated risks to the fetus. Healthcare professionals should consider the potential benefits and risks when prescribing this medication to pregnant patients, as well as the lack of definitive information regarding its safety profile in this population.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the 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 teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a container that is designed to maintain its integrity under normal handling conditions. It is essential to store the product in a location where temperatures do not exceed 120˚F. The container must be kept away from fire or flame to prevent any risk of combustion.

Due to the contents being under pressure, it is critical to avoid puncturing or incinerating the container. Additionally, this product should be kept out of reach of children to ensure safety. Proper handling and storage are vital to maintain the efficacy and safety of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 Anti-Itch, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.