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| Product NDC Code | 70108-108 | ||||
|---|---|---|---|---|---|
| Drug Name | Brush buddies crayola swirl anticavity fluoride watermelon flavor |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 2701521 | ||||
| Application Number | M021 | ||||
| Labeler Name | Ashtel Studios, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium Fluoride 0.221% w/w (Fluoride ion content 1000 ppm)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. • Do not swallow. • Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. • Children under 2 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sorbitol, Aqua, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Blue 1, Yellow 5, Red 30, Blue 15, Mica, Titanium Dioxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses helps protect against cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVOR Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SACCHARIN SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5 D&C RED NO. 30 PHTHALOCYANINE BLUE MICA TITANIUM DIOXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging Brush Buddies® Crayola Swirl ANTICAVITY FLUORIDE TOOTHPASTE
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
HELPS PREVENT CAVITIES COLOR CHANGING GREEN TO PURPLE make brushing fun! ® CAUTION: AVOID EXCESSIVE INGESTION. NOT FOR PETS. NOT TESTED ON ANIMALS. EC No. GUJ/COS/GC-679 OFFICIAL LICENSED PRODUCT DESIGNED IN U.S.A. • MADE IN INDIA QUALITY GUARANTEE Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday - Friday 8AM - 5PM. PST ABOUT US Crayola A Hallmark Company ©2025 CRAYOLA, EASTON, PA 18044-0431. Crayola™, and Serpentine Design™ are trademarks of Crayola used under license. Toothpaste changes color from GREEN. to PURPLE, indicating effective brushing. Encourages children to brush for 2 minutes. Helps maintain a bright smile and a healthy mouth.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll free 1-877-274-8358
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API