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Drug Facts
Smarth
FDA Label NDC 60927-115
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Carib Sales, Llc for the product Smarth (NDC 60927-115). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, principal display panel - 181g tube carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)
Purpose
AntiCavity Toothpaste
Use
aids in the prevention of dental cavities
Otc - Keep Out Of Reach Of Children
Keep out of the 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 immediately
Directions
- Do not swallow
- Supervise children as necessary until capable of using without supervision
- Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
- Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
- Children under 6 years of age: Do not use unless directed by a doctor or dentist
Inactive Ingredients
Sorbitol, Hydrated Silica, Demineralized Water, Sodium Lauryl Sulphate, Sodium Bicarbonate, Sod. CMC, Flavor, Sodium Benzoate, Sodium Saccharin
Principal Display Panel - 181G Tube Carton
SMARTH™
Extra Strength Fluoride Toothpaste
BAKING SODA
NET WT 6.4 Oz [181g]
Principal Display Panel (181g Tube Carton)
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