Label: LUCKY SUPER SOFT ANTI CAVITY- sodium monofluorophosphate paste, dentifrice
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated December 28, 2018
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- Active ingredient
- Keep out of the reach of children
adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician
- Inactive ingredients
- Package Label
INGREDIENTS AND APPEARANCE
LUCKY SUPER SOFT ANTI CAVITY
sodium monofluorophosphate paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20276-554 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) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM SILICATE (UNII: IJF18F77L3) SORBITOL (UNII: 506T60A25R) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20276-554-01 2 in 1 BOX 03/31/2017 1 NDC:20276-554-04 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/31/2017 Labeler - Delta Brands Inc (102672008)