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| Product NDC Code | 37808-961 | ||||
|---|---|---|---|---|---|
| Drug Name | Heb extra whitening |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 1038929 | ||||
| Application Number | M022 | ||||
| Labeler Name | HEB | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (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 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth. Do not swallow Children under 12 years of age: consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum
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 builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose Antihypersensitivity Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.HEB Extra Whitening Fluoride WATER SACCHARIN SODIUM SODIUM TRIPOLYPHOSPHATE POLYETHYLENE GLYCOL 400 SORBITOL TITANIUM DIOXIDE SODIUM HYDROXIDE GLYCERIN XANTHAN GUM HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION mint
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® SENSITIVE MAXIMUM STRENGTH WITH FLUORIDE Toothpaste for Sensitive Teeth & Cavity Protection Fresh Mint EXTRA WHITENING NET WT. 4 OZ (113 g) HEB - 961
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 MADE IN USA
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 . 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 1-877-777-2748
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
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 If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and ask a dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children . 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