LUCKY SUPER SOFT ANTI CAVITY- sodium monofluorophosphate paste, dentifrice 
Delta Brands Inc

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.

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Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (Total fluoride content-1000 ppm approx.)

Purpose

Anticavity

Use

regular brushing with fluoride toothpaste helps protect teeth against cavities

Keep out of the reach of children

under 6 years of age

Warnings

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

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

calcium carbonate, flavor, polyethylene glycol 400, potassium sorbate, precipitated silica, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, tetra sodium pyrophosphate, titanium dioxide, water

Package Label

Package Label

LUCKY SUPER SOFT  ANTI CAVITY
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-554
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-554-012 in 1 BOX03/31/2017
1NDC:20276-554-04113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/31/2017
Labeler - Delta Brands Inc (102672008)

Revised: 12/2018
Document Id: 7e18b22d-0062-c0c0-e053-2991aa0ab53c
Set id: 4d24da8e-1eb3-20ca-e054-00144ff88e88
Version: 4
Effective Time: 20181228
 
Delta Brands Inc