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| Product NDC Code | 44873-007 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Go smile relax |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | PASTE, DENTIFRICE | ||||||
| RxCUI drug identifier | 545626 | ||||||
| Application Number | M021 | ||||||
| Labeler Name | Go Smile, Inc. | ||||||
| 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 SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% W/V FLUORINE 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 THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS. INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS SORBITOL, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN, SODIUM BENZOATE, VALERIAN OFFICINALIS RHIZOME/ROOT EXTRACT.
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.PURPOSE ANTICAVITY
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.Go Smile RELAX SODIUM MONOFLUOROPHOSPHATE SORBITOL WATER HYDRATED SILICA GLYCERIN SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE SODIUM BENZOATE SACCHARIN SODIUM VALERIAN SODIUM MONOFLUOROPHOSPHATE 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.GO SMiLE PM 1.0 ozTube_V5_7_11 GO SMiLE PM 3.5 ozTube_V4_7_11
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.WARNINGS: KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.
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 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