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Product NDC Code | 37808-896 | ||||
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Drug Name | Heb brilliant white |
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Type | Brand | ||||
Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | PASTE, DENTIFRICE | ||||
RxCUI drug identifier | 545626 | ||||
Application Number | part355 | ||||
Labeler Name | HEB | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium Monofluorophosphate 0.76% w/w (0.15% w/v fluoride ion)
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 of age and older: brush teeth thorughly preferably after each meal or at least twice per day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing). Supervise children as necessary until capable of using without supervision. 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 glycerin, dicalcium phosphate, propylene glycol, PEG-12, PVP, silica, PEG/PPG 116/66 copolymer, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, hydrogen peroxide, etidronic acid, butylated hydroxytoluene, sodium saccharin, sucralose, phosphoric acid, water
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 aids in the prevention of dental caviites
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.HEB Brilliant White Fluoride GLYCERIN SODIUM PYROPHOSPHATE POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SACCHARIN SODIUM SUCRALOSE BUTYLATED HYDROXYTOLUENE PEG/PPG-116/66 COPOLYMER PHOSPHORIC ACID CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS HYDRATED SILICA SODIUM LAURYL SULFATE ETIDRONIC ACID WATER HYDROGEN PEROXIDE CROSPOVIDONE, UNSPECIFIED SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION L Menthol
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.H-E-B® Dazzling Mint BRILLIANT WHITE FLUORIDE ANTICAVITY TOOTHPASTE NET WT. 5 OZ (141.7 g) HEB BRILLIANT WHITE 2821228R3
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
MADE WITH PRIDE AND CARE FOR H-E-B® SAN ANTONIO, TX 78204
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 more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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 1-877-777-2743
Storage and handling
Information about safe storage and handling of the drug product.Store in a cool dry place. Keep tube capped when not in use.
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 more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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