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| Product NDC Code | 37808-230 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | H e b restore and defend |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | DENTAL | ||||||
| Dosage Form | PASTE, DENTIFRICE | ||||||
| RxCUI drug identifier | 416784 | ||||||
| Application Number | part356 | ||||||
| Labeler Name | HEB | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Stannous Fluoride 0.454% (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 directed by a dentist or physician. 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 water, glycerin, hydrated silica, sodium tripolyphosphate, sodium saccharin, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium lauryl sulfate, flavor
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 cavities builds increasing protection against painful sensitivity of the teeth to cold, heat, acids sweets or contact
Purpose
Information about the drug product’s indications for use.Purpose Anticavity/Antihypersensitivity
Spl product data elements
Usually a list of ingredients in a drug product.H E B Restore and Defend Fluoride SORBITOL GLYCERIN SACCHARIN SODIUM WATER TITANIUM DIOXIDE SODIUM TRIPOLYPHOSPHATE ANHYDROUS CARBOXYMETHYLCELLULOSE SODIUM COCAMIDOPROPYL BETAINE SODIUM LAURYL SULFATE HYDRATED SILICA STANNOUS FLUORIDE FLUORIDE ION
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® Fresh Mint SENSITIVE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION RESTORE & DEFEND Daily protection for sensitive teeth Removes stains for whiter teeth TWIN PACK 2 Tubes of 3.4 OZ (96.3g); TOTAL NET WT. 6.8 OZ (192.6g) HEB RESTORE DEFEND 2PK 2821273R1
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. 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
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 persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, if irritation occurs discontinue use.
Storage and handling
Information about safe storage and handling of the drug product.Other information products containing stannous fluoride may produce surface staining of the teeth. Adequate brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. This product is specifically formulated to help prevent staining. store below 30°C (86°)F
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 When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if: the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use 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