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Crest

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Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
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
Dental
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
Procter & Gamble Manufactura, S. de R. L. de C. V.
Registration number
M021
NDC root
58933-045

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 is a fluoride anticavity toothpaste designed to help protect your teeth against cavities. It is suitable for individuals aged 3 years and older, making it a great option for families. One of the fun variants available is the Marvel Spider-Man Strawberry flavor, which can make brushing more enjoyable for kids. Each tube contains 4.2 oz (119 g) of this protective toothpaste, ensuring you have enough for regular use.

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) associated with this product, making it safe for use without concerns in that regard.

Dosage and Administration

To use this medication effectively, start by twisting off the cap to remove the foil seal. If you are an adult or a child aged 2 years and older, you should brush your teeth thoroughly after meals or at least twice a day. It's important not to swallow the medication. For children under 6, use only a pea-sized amount to help minimize swallowing, and make sure to supervise their brushing until they develop good habits.

If your child is under 2 years old, it's best to consult with a dentist before using this product. Following these guidelines will help ensure that you or your child use the medication safely and effectively.

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years old to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, always follow the usage instructions carefully to ensure your safety and well-being.

Side Effects

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

Always be cautious and ensure that this product is used as directed to avoid any potential issues.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to prevent accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, 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, stop using the product and call your doctor for further advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, 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.

While there are no specific signs of overdose listed, being aware of any unusual symptoms after swallowing too much is important. If you notice anything concerning, don’t hesitate to reach out for help. Always prioritize your health and safety by acting quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the use of this medication while nursing. This means that the effects on breast milk production and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

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 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

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the usual guidelines for safety and precautions for elderly patients have not been established.

If you or a caregiver are considering this medication, it’s important to consult with a healthcare professional who can provide personalized advice based on your health needs and any other medications you may be taking. Always prioritize open communication with your doctor 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to consult with your healthcare provider about your specific situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver 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 dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health. Regular liver function tests (which check how well your liver is working) may also be recommended to monitor your condition. Always keep your doctor informed about your liver health when discussing treatment options.

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 full list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it away from freezing temperatures, as exposure to cold can affect its effectiveness.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance.

Additional Information

The medication is administered through the dental route, meaning it is used in the mouth. It's important that you do not swallow the medication. If you are using it for children under 6 years old, use only a pea-sized amount to help minimize swallowing. Additionally, make sure to supervise children's brushing until they develop good habits. If your child is under 2 years old, consult a dentist before use.

FAQ

What is CREST?

CREST is a fluoride anticavity toothpaste designed to help protect against cavities.

Who can use CREST?

CREST is intended for use by individuals aged 3 years and older.

What should I do if a child under 2 years wants to use CREST?

If a child is under 2 years old, you should ask a dentist before use.

How should I use CREST?

Brush your teeth thoroughly after meals or at least twice a day, or use as directed by a dentist. Do not swallow the toothpaste.

What precautions should I take when using CREST with children?

Supervise children's brushing until good habits are established, and use a pea-sized amount for children under 6 to minimize swallowing.

Are there any contraindications for using CREST?

No contraindications are listed for CREST.

What should I do if more than the recommended amount of CREST is swallowed?

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

How should I store CREST?

Store CREST at room temperature and protect it from freezing.

Does CREST have any teratogenic effects?

No teratogenic effects are mentioned for CREST.

Is there any information about using CREST during pregnancy or lactation?

No specific information regarding the use of CREST during pregnancy or lactation is provided.

Packaging Info

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

Packaging configurations for Crest.
Details

Drug Information (PDF)

This file contains official product information for Crest, 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 protection against cavities.

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

Dosage and Administration

Twist off the cap to remove the foil seal prior to use. For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist. It is important to avoid swallowing the product. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years of age. Caregivers should supervise children's brushing until proper oral hygiene habits are established.

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

Contraindications

Use is contraindicated in children under 6 years of age. Due to the potential risk of accidental ingestion, if more than the recommended amount for brushing is swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount used for brushing 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 and care.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is imperative to keep the product out of reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount used for brushing is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately. This precaution is essential to ensure the safety and well-being of patients, particularly young children who may be at higher risk of adverse effects from ingestion.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Crest.
Details

Pediatric Use

Pediatric patients under 6 years of age should be supervised during brushing to establish good oral hygiene habits. It is recommended that a pea-sized amount of the product be used to minimize swallowing in this age group. 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.

In children under 2 years of age, consultation with a dentist is recommended prior to use. Care should be taken to keep the product out of reach of young children. In the event of accidental swallowing of more than the amount used for brushing, medical assistance or contact with a Poison Control Center should be sought immediately.

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 is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there are no data on the excretion of this medication in human breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the potential risks and benefits.

Overdosage

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is crucial to ensure the safety and well-being of the individual involved.

Currently, there is no specific overdosage information available regarding the substance in question. However, healthcare professionals should remain vigilant for any potential symptoms that may arise from excessive ingestion and be prepared to manage them accordingly.

In summary, any instance of overdosage should be treated as a medical emergency, necessitating swift communication with medical professionals or poison control authorities to facilitate appropriate intervention.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is protected from freezing to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients not to swallow the product. For children under 6 years of age, it is recommended to use a pea-sized amount to minimize swallowing, and parents should supervise children's brushing until proper habits are established. Additionally, for children under 2 years, consultation with a dentist is advised.

Drug Information (PDF)

This file contains official product information for Crest, 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, 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.