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| Product NDC Code | 37808-331 | ||||
|---|---|---|---|---|---|
| Drug Name | Heb dry mouth |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 891775 | ||||
| Application Number | M021 | ||||
| Labeler Name | HEB | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium Fluoride (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 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 physician. Children under 12 years of age: consult a dentist or physician. Once recommended, to minimize swallowing for children under 6,use a pea sized amount and supervise brushing until good habits are established.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide.
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.Use aids in the prevention of dental 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.HEB Dry Mouth Sodium fluoride GLYCERIN SACCHARIN SODIUM WATER SODIUM HYDROXIDE TITANIUM DIOXIDE SUCRALOSE HYDRATED SILICA COCAMIDOPROPYL BETAINE SORBITOL POLYETHYLENE GLYCOL, UNSPECIFIED XANTHAN GUM SODIUM 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® DRY MOUTH FLUORIDE ANTICAVITY TOOTHPASTE Fresh Mint NET WT. 4.3 OZ (122g) HEB Drymouth 2821290R1
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.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 12 years of age and under. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information 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
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