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Rephresh Cooling

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This product has been discontinued

Active ingredient
Hydrocortisone 500 g/1 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
June 12, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 500 g/1 g
Other brand names
Dosage form
Spray
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 2018
Label revision date
June 12, 2018
Manufacturer
Fleet Laboratories LTD
Registration number
part348
NDC root
70233-774
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

RepHresh™ Vaginal Anti-Itch Spray is a cooling relief spray designed to provide temporary relief from external feminine itching. It contains 0.5% hydrocortisone, which is a type of medication that helps reduce inflammation and itching. This product is gynecologist recommended and is known as the #1 trusted brand for addressing these concerns.

If you're experiencing discomfort, this unscented spray can help soothe your symptoms. However, it's important to use it as directed and consult with a doctor for any other uses.

Uses

If you're experiencing temporary external feminine itching, this product can help provide relief. It's important to use this product as directed and only under the advice and supervision of a doctor for any other uses.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safer option for those concerned about such risks. Always consult with your healthcare provider if you have any questions or need further guidance.

Dosage and Administration

Before you use the medication for the first time, make sure to pump the spray 3 to 5 times. This helps ensure that the medication dispenses properly. Once you’ve done that, give the tube a gentle shake to mix the contents well.

When you’re ready to apply the spray, hold the tube about 6 inches away from the vaginal area. Press down quickly and firmly to release one spray. If you need to, the tube is designed to work even when held upside down, making it easier for you to apply the medication as needed.

What to Avoid

You should avoid using this medication if you have vaginal discharge, as it is contraindicated in such cases. Additionally, it's important to follow the dosage instructions carefully; do not use more than directed unless your doctor advises you to do so. Always prioritize your health and consult with a healthcare professional if you have any questions or concerns.

Side Effects

This product is intended for external vaginal use only. If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, you should stop using the product and consult a doctor. Additionally, do not start using any other hydrocortisone product without first speaking to a healthcare professional.

If you have a known allergy to any ingredient in this product, it’s important to consult your doctor or pharmacist before use.

Warnings and Precautions

This product is intended for external vaginal use only. It's important to keep it out of reach of children. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. Do not use this product if you have vaginal discharge, and make sure to follow the dosage instructions carefully—do not exceed the recommended amount unless directed by your doctor.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Avoid starting any other hydrocortisone product without first talking to your doctor.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When considering the use of RepHresh Cooling - hydrocortisone spray 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 product on pregnancy have not been clearly studied or established.

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 products like this spray. Your doctor can help you weigh the potential risks and benefits based on your individual health needs.

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 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 under 12 years old, it's important not to use this medication without first consulting a doctor. For older children and adults, you can apply the medication to the affected area, but be 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

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients 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 kidney health. They can provide guidance based on your individual situation.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 and safety of your product, store it at room temperature, away from heat and direct sunlight. This helps maintain its effectiveness. Always check the safety seal before use; do not use the product if the seal is broken or missing, as this could indicate that it is no longer safe to use. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is RepHresh™ Vaginal Anti-Itch Spray used for?

RepHresh™ Vaginal Anti-Itch Spray is used for the temporary relief of external feminine itching.

How should I apply RepHresh™ Vaginal Anti-Itch Spray?

You should pump the spray 3-5 times before first use, shake gently, hold the tube 6 inches away from the vaginal area, and apply 1 quick, firm spray.

How often can I use this spray?

Adults and children 12 years and older can apply it to the affected area up to 3 to 4 times daily.

Are there any contraindications for using this spray?

Do not use RepHresh™ Vaginal Anti-Itch Spray if you have vaginal discharge.

What should I do if my symptoms persist?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if they clear up and occur again within a few days.

Is this product safe for children?

Children under 12 years of age should not use this product without consulting a doctor.

What precautions should I take when using this spray?

Keep the spray out of reach of children, do not use if the safety seal is broken or missing, and avoid using it more than directed unless advised by a doctor.

Can I use this spray during pregnancy or while nursing?

There is no specific information regarding the use of this product during pregnancy or lactation, so consult your doctor for advice.

What should I do if I accidentally swallow the spray?

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

Is RepHresh™ Vaginal Anti-Itch Spray gynecologist recommended?

Yes, it is a gynecologist-recommended product and is considered the #1 trusted brand.

Packaging Info

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

Packaging configurations for Rephresh Cooling.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

RepHresh™ Vaginal Anti-Itch Spray is a topical formulation designed to provide cooling relief for vaginal itching. This product contains 0.5% hydrocortisone as its active ingredient, which is known for its anti-inflammatory properties. The spray is unscented and is packaged in a 0.50 fluid ounce (15 mL) container. It is the #1 trusted brand in its category and is recommended by gynecologists for its efficacy in alleviating discomfort.

Uses and Indications

This drug is indicated for the temporary relief of external feminine itching. Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Prior to the initial use, the tube should be pumped 3 to 5 times to ensure proper dispensing of the product. It is essential to shake the tube gently before each application to achieve optimal consistency.

For administration, the healthcare professional should instruct the patient to hold the tube approximately 6 inches away from the vaginal area. The product should be applied using one quick, firm spray. It is important to note that the tube is designed to function effectively even when held upside down, allowing for flexibility in application.

Contraindications

Use is contraindicated in patients with vaginal discharge. Additionally, the product should not be used in excess of the directed dosage unless specifically instructed by a healthcare professional.

Warnings and Precautions

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

This product should not be used in the presence of vaginal discharge. Users are advised to adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed to do so by a healthcare professional.

Patients should discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, users should refrain from initiating the use of any other hydrocortisone product without prior consultation with a healthcare provider.

In case of ingestion, it is crucial to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware that it is intended for external vaginal use only. In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. Additionally, patients should not begin the use of any other hydrocortisone product without prior consultation with a healthcare professional.

It is also important for patients to consult a doctor or pharmacist if they have a known allergy to any ingredient in this product.

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 Rephresh Cooling (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rephresh Cooling.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For those aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Care should be taken to adhere to these guidelines to ensure safety and efficacy in this population.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of RepHresh Cooling - hydrocortisone spray during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this product for women of childbearing potential. It is advisable to exercise caution and consult relevant clinical guidelines or experts when addressing the use of this product in pregnant patients.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials, and there is no available information regarding dosage adjustments, special monitoring, or precautions for this population. Therefore, the safety and efficacy of the medication in patients with compromised liver function remain undetermined. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, considering the lack of data and potential risks associated with altered drug metabolism in this population.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product if they have vaginal discharge. It is important to emphasize that they should not exceed the recommended dosage unless directed by a healthcare professional.

Healthcare providers should counsel patients to discontinue use 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. Additionally, patients should be advised not to begin the use of any other hydrocortisone product without first consulting a doctor.

Patients should be cautioned to avoid contact with their eyes while using this product. Finally, healthcare providers should recommend that patients consult a doctor if they have a known allergy to any ingredient in the product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, away from heat sources and direct sunlight to maintain its integrity. It is essential to ensure that the safety seal is intact; the product should not be used if the safety seal is broken or missing. Proper handling and storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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

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

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

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

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

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