Label: SMARTH EXTRA STRENGTH WHITENING- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 60927-118-13 - Packager: Carib Sales, LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 8, 2013
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warning
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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
- PRINCIPAL DISPLAY PANEL - 181g Tube Carton
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INGREDIENTS AND APPEARANCE
SMARTH EXTRA STRENGTH WHITENING
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60927-118 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride ion - UNII:Q80VPU408O) Fluoride ion 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength Calcium Carbonate (UNII: H0G9379FGK) Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Sodium Pyrophosphate (UNII: O352864B8Z) Sodium Lauryl Sulfate (UNII: 368GB5141J) Hydrated Silica (UNII: Y6O7T4G8P9) Sodium Silicate (UNII: IJF18F77L3) Sodium Benzoate (UNII: OJ245FE5EU) Saccharin Sodium (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60927-118-13 1 in 1 CARTON 1 181 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 12/01/2013 Labeler - Carib Sales, LLC (081234528) Registrant - Vikshara Trading & Investment Ltd (675920690) Establishment Name Address ID/FEI Business Operations Vikshara Trading & Investment Ltd 675920690 MANUFACTURE(60927-118)