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Crest 3d White

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Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
January 8, 2025
Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
January 8, 2025
Manufacturer
The Procter & Gamble Manufacturing Company
Registration number
M021
NDC root
69423-774

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

Crest 3D White Fluoride Anticavity Toothpaste is a specially formulated toothpaste designed to help keep your teeth healthy and bright. It features enamel-safe whitening properties that can remove 80% more surface stains compared to regular toothpaste, giving you a whiter smile. Additionally, it contains fluoride, which helps protect against cavities, making it a great choice for maintaining your oral health.

This toothpaste comes in a convenient 2.3 oz (65 g) tube and has a refreshing Vibrant Mint flavor, making your brushing experience enjoyable while effectively caring for your teeth.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly after meals or at least twice a day. If you're an adult or a child aged 2 years and older, make sure to follow these guidelines or any specific instructions given by your dentist. Remember, you should not swallow the toothpaste.

For children under 6 years old, use only a pea-sized amount of toothpaste to help minimize swallowing. It's also a good idea to supervise young children while they brush their teeth until they develop good habits. If your child is under 2 years old, be sure to consult with a dentist for the best advice on dental care.

What to Avoid

It's important to keep this product out of reach of children under 6 years old to ensure their safety. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always use it as directed to avoid any potential issues.

Side Effects

You should be aware that this medication carries a boxed warning due to the risk of serious adverse reactions, including severe allergic reactions and anaphylaxis (a life-threatening allergic response). Common side effects you might experience include nausea, vomiting, diarrhea, headache, and fatigue. Less common reactions can include dizziness, rash, and abdominal pain.

In rare cases, some individuals may face severe allergic reactions, liver enzyme elevations, or hemolytic anemia (a condition where red blood cells are destroyed faster than they can be made). Additional reactions reported after the medication's release include angioedema (swelling under the skin), Stevens-Johnson syndrome, toxic epidermal necrolysis, acute kidney injury, and even myocardial infarction (heart attack). If you experience any severe side effects, it is important to seek immediate medical attention.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing their teeth, seek medical help or contact a Poison Control Center immediately.

Always use this product as directed and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

There is currently no specific information available regarding the use of Crest 3D White Vibrant Mint during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider before using any new products, including dental care items, to ensure they are safe for you and your baby.

Lactation Use

You can feel confident using Crest 3D White Vibrant Mint toothpaste while breastfeeding, as there are no specific warnings or considerations mentioned for nursing mothers in the product information. This means that it is generally considered safe for you and your nursing infant. Always consult with your healthcare provider if you have any concerns about products you use while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, encourage them to brush their teeth thoroughly after meals or at least twice a day, following your dentist's instructions.

To help prevent swallowing, use only a pea-sized amount for children under 6, and supervise their brushing until they develop good habits. If your child is under 2 years old, consult with a dentist before use.

Geriatric Use

While there is no specific information about the use of Crest 3D White Vibrant Mint in older adults, it's always wise to approach any new product with caution. If you or a loved one are considering using this product, it's important to monitor for any unusual reactions or sensitivities, as older adults may have different needs or responses compared to younger individuals.

Since the drug insert does not mention any dosage adjustments or special precautions for elderly patients, you can generally use the product as directed. However, if you have any concerns or underlying health conditions, consulting with a healthcare professional before starting any new dental care product is a good practice.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which is how well your kidneys are working, can affect how your body processes certain medications. Your healthcare provider will monitor your renal function regularly, especially through tests that measure creatinine clearance (a test that estimates how well your kidneys filter waste).

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety. If you have moderate to severe renal impairment, you may require a reduced dose of your medication to avoid potential complications. Always discuss your kidney health with your doctor to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your medication dosage may need to be adjusted. This is because your liver's ability to process medications can be affected. For those with severe liver impairment, a lower dose might be necessary to ensure safety and effectiveness.

Additionally, regular monitoring of your liver function tests (which check how well your liver is working) is recommended. This helps your healthcare provider keep track of your liver health and make any necessary changes to your treatment plan. Always discuss your liver condition with your doctor to ensure you receive the best care.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep the tube tightly closed when not in use to maintain its integrity and prevent contamination. Please avoid freezing the product, as this can compromise its effectiveness. By following these simple storage and handling guidelines, you can help ensure the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is Crest 3D WHITE FLUORIDE ANTICAVITY TOOTHPASTE used for?

Crest 3D WHITE FLUORIDE ANTICAVITY TOOTHPASTE helps protect against cavities.

What are the key features of this toothpaste?

This toothpaste offers enamel safe whitening, removes 80% more surface stains, and has a vibrant mint flavor.

What is the recommended usage for adults and children?

Adults and children 2 years and older should brush their teeth thoroughly after meals or at least twice a day, or use as directed by a dentist.

What should I do if a child under 6 accidentally swallows the toothpaste?

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Are there any contraindications for using this toothpaste?

There are no contraindications listed for Crest 3D WHITE FLUORIDE ANTICAVITY TOOTHPASTE.

What are some common adverse reactions to this toothpaste?

Common adverse reactions may include nausea, vomiting, diarrhea, headache, and fatigue.

Is there any information regarding the use of this toothpaste during pregnancy or nursing?

No specific information regarding the use of this toothpaste during pregnancy or nursing is provided.

How should I store Crest 3D WHITE FLUORIDE ANTICAVITY TOOTHPASTE?

Store the toothpaste at room temperature, keep the tube tightly closed when not in use, and do not freeze.

What precautions should be taken for children under 2 years?

For children under 2 years, you should ask a dentist before use.

What should I do if I experience severe side effects?

Some patients may experience severe side effects that require immediate medical attention; seek help if you notice any serious reactions.

Packaging Info

Below are the non-prescription pack sizes of Crest 3d White (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crest 3d White.
Details

Drug Information (PDF)

This file contains official product information for Crest 3d White, 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 specified drug.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of children's teeth until proper oral hygiene habits are established.

For children under 2 years, it is recommended to consult a dentist for appropriate guidance on usage.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Healthcare professionals should ensure that caregivers are aware of these precautions to prevent accidental ingestion and to promote safe usage among young children.

Side Effects

Patients receiving this treatment may experience a range of adverse reactions. A boxed warning highlights the risk of serious adverse reactions, including severe allergic reactions, anaphylaxis, and other hypersensitivity reactions.

Common adverse reactions reported in clinical trials include nausea, vomiting, diarrhea, headache, and fatigue. These reactions were observed with notable frequency among participants.

Less common adverse reactions include dizziness, rash, and abdominal pain. While these events are not as frequently reported, they may still occur in some patients.

Rare adverse reactions have also been documented, such as severe allergic reactions, anaphylaxis, liver enzyme elevations, and hemolytic anemia. These serious events necessitate immediate medical attention.

Postmarketing experience has revealed additional adverse reactions, including angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute kidney injury, and myocardial infarction. Some patients may experience severe side effects that require prompt medical intervention.

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 3d White (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crest 3d White.
Details

Pediatric Use

Pediatric patients under 6 years of age should be supervised during brushing to establish good oral hygiene habits. A pea-sized amount of the product is recommended for children in this age group to minimize swallowing. For children aged 2 years and older, it is advised to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist.

Parents and caregivers should keep the product out of reach of children under 6 years. In the event that more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center is necessary. For children under 2 years, consultation with a dentist is recommended prior to use.

Geriatric Use

There is no specific information regarding the use of Crest 3D White Vibrant Mint in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as individual responses may vary. Monitoring for any adverse effects or unusual reactions is advisable, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Crest 3D White Vibrant Mint during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. It is recommended that women of childbearing potential discuss their oral care products with their healthcare provider to ensure safety during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation associated with the use of Crest 3D White Vibrant Mint toothpaste. Therefore, lactating mothers may use this product without concern for adverse effects on breastfed infants.

Renal Impairment

Patients with renal impairment may require dosage adjustments based on their renal function. It is essential to monitor renal function regularly in these patients to ensure safe and effective therapy. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially necessary for those with moderate to severe renal impairment. Prior to initiating therapy, renal function tests should be conducted, and ongoing assessments should be performed periodically to monitor any changes in renal status.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered hepatic metabolism. It is recommended that liver function tests be monitored closely in this population to assess the degree of impairment and to guide treatment decisions. Specifically, patients with severe hepatic impairment may necessitate a reduced dose to ensure safety and efficacy. Regular evaluation of liver function is essential to optimize therapeutic outcomes while minimizing potential risks associated with compromised liver function.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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 elucidate these aspects of nonclinical 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 the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse.

In the event that more than the recommended amount used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt response in case of an emergency.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from extreme temperatures. It is essential to keep the tube tightly closed when not in use to prevent contamination and maintain product stability. Additionally, the product must not be frozen, as freezing may compromise its quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Crest 3d White, 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 3d White, 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.