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Crest Pro-Health

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Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
March 7, 2025
Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2015
Label revision date
March 7, 2025
Manufacturer
The Procter & Gamble Manufacturing Company
Registration number
M021
NDC root
37000-867

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Drug Overview

CREST PRO-HEALTH ADVANCED ANTICAVITY FLUORIDE RINSE is a mouthwash designed to help prevent dental cavities and promote oral health. This alcohol-free rinse not only aids in cavity prevention but also strengthens tooth enamel and freshens your breath by killing bad breath germs. With its extra whitening formula, you can expect a whiter smile in just seven days.

Using this rinse regularly can be an effective part of your dental care routine, helping you maintain a healthy mouth and a confident smile.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

Dosage and Administration

After brushing your teeth with toothpaste, you should use the mouth rinse twice a day. To do this, take 10 mL (which is about 2 teaspoonfuls) of the rinse and swish it vigorously between your teeth for one minute before spitting it out. It's important not to swallow the rinse. After using it, avoid eating or drinking anything for 30 minutes to allow the rinse to work effectively.

If you're helping children under 12 years old, make sure to teach them proper rinsing habits to prevent swallowing the rinse. You should supervise them until they can rinse without assistance. For children under 12, it's best to consult a dentist or doctor before using the rinse.

What to Avoid

It's important to be aware of certain precautions when using this product. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should take care not to swallow more than what is intended for rinsing. If you accidentally swallow a larger amount, seek medical assistance or contact a Poison Control Center immediately. Your safety is a priority, so please use the product as directed.

Side Effects

It's important to keep this product out of reach of children. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. This ensures your safety and addresses any potential risks associated with misuse.

Warnings and Precautions

It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is intended for rinsing, seek medical help immediately or contact a Poison Control Center.

Always use this product as directed, and if you have any concerns or experience unusual symptoms, stop using it and call your doctor for advice. Your safety is a priority, so please take these precautions seriously.

Overdose

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose can vary, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

There is currently no specific information available about the use of Crest Pro-Health Advanced with Extra Whitening (sodium fluoride rinse) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's guidelines.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any new products, including oral care items, to ensure they are safe for you and 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 associated with its use during lactation. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children. If a child accidentally swallows more than the amount used for rinsing, seek medical help or contact a Poison Control Center immediately. For adults and children aged 12 and older, the recommended use is twice a day after brushing teeth. You should swish 10 mL (2 teaspoonfuls) of the rinse between your teeth for one minute and then spit it out, avoiding swallowing. After rinsing, do not eat or drink for 30 minutes.

For children under 12, it's best to consult a dentist or doctor before use. If you do allow them to use the rinse, make sure to teach them proper rinsing techniques to reduce the risk of swallowing, and supervise them until they can rinse safely on their own.

Geriatric Use

While there is no specific information about the use of Crest Pro-Health Advanced Extra Whitening sodium fluoride rinse in older adults, it's always wise to approach any new product with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before starting this rinse, especially if you have any underlying health conditions or are taking other medications.

As you age, your body may process substances differently, so it's important to ensure that any oral care product you use is safe and effective for your individual needs. Always prioritize your health and well-being by discussing any new treatments with your doctor or pharmacist.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and avoid freezing it, as extreme cold can damage the contents. When not in use, make sure to keep the bottle tightly closed to maintain its integrity. Remember to discard the product after opening to ensure safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, using it twice a day after brushing your teeth. To use the rinse, vigorously swish 10 mL (which is about 2 teaspoonfuls) between your teeth for 1 minute, then spit it out. Remember not to swallow the rinse, and avoid eating or drinking for 30 minutes after using it.

If you have children under 12, make sure to teach them proper rinsing habits to prevent swallowing the rinse. It's important to supervise them until they can use it safely on their own. If you have any concerns about children under 12 using this product, consult a dentist or doctor.

FAQ

What is CREST PRO-HEALTH ADVANCED ANTICAVITY FLUORIDE RINSE used for?

It aids in the prevention of dental cavities and helps strengthen enamel.

How should I use this mouth rinse?

Use twice a day after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) for 1 minute and then spit it out. Do not swallow the rinse and avoid eating or drinking for 30 minutes after rinsing.

Is this product safe for children?

Children under 12 years of age should consult a dentist or doctor. Instruct them in good rinsing habits and supervise their use.

Are there any contraindications for this mouth rinse?

No contraindications are listed for CREST PRO-HEALTH ADVANCED ANTICAVITY FLUORIDE RINSE.

What should I do if I accidentally swallow more than the recommended amount?

Get medical help or contact a Poison Control Center right away.

Can I use this product during pregnancy or while nursing?

There is no specific information regarding use during pregnancy or lactation provided in the product insert.

How should I store this mouth rinse?

Store at room temperature, keep the bottle tightly closed when not in use, and do not freeze. Discard after opening.

What are the key benefits of using this mouth rinse?

It kills bad breath germs, freshens breath, and can help achieve a whiter smile in 7 days.

Packaging Info

Below are the non-prescription pack sizes of Crest Pro-Health (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crest Pro-Health.
Details

Drug Information (PDF)

This file contains official product information for Crest Pro-Health, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 12 years and older are instructed to use the rinse twice daily, following brushing with toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes post-rinsing to ensure optimal efficacy.

For children under 12 years of age, it is advised to consult a dentist or physician prior to use. Caregivers should instruct children in proper rinsing techniques to minimize the risk of swallowing the rinse and should supervise the rinsing process as necessary until the child is capable of performing the task independently.

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event that more than the recommended amount used for rinsing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Crest Pro-Health (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crest Pro-Health.
Details

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For pediatric patients aged 12 years and older, the recommended usage is twice daily after brushing teeth with toothpaste. They should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. It is important that they do not swallow the rinse and refrain from eating or drinking for 30 minutes following the rinse.

For children under 12 years of age, it is essential to consult a dentist or doctor prior to use. Additionally, caregivers should instruct younger children in proper rinsing techniques to minimize the risk of swallowing the rinse and supervise them as necessary until they are capable of using the product without assistance.

Geriatric Use

There is no specific information regarding the use of Crest Pro-Health Advanced Extra Whitening sodium fluoride rinse in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when recommending this product to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of the patient's overall health status.

Pregnancy

There is no specific information regarding the use of Crest Pro-Health Advanced with Extra Whitening (sodium fluoride rinse) during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established in the drug insert. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of this product during pregnancy.

Lactation

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

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 relation to 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 assistance is crucial. If an individual accidentally swallows more than the amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for rinsing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in a bottle that must be stored at room temperature. It is essential to avoid freezing the product to maintain its integrity. When not in use, the bottle should be kept tightly closed to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

Patients should administer the rinse orally, using 10 mL (2 teaspoonfuls) twice a day after brushing their teeth. The rinse should be vigorously swished between the teeth for 1 minute before spitting it out. It is important that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes following the rinsing.

Clinicians should advise that children under 12 years of age be instructed in proper rinsing techniques to minimize the risk of swallowing. Supervision may be necessary until the child is capable of using the rinse independently. Additionally, consultation with a dentist or doctor is recommended for children in this age group.

Drug Information (PDF)

This file contains official product information for Crest Pro-Health, 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 Crest Pro-Health, 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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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.