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Lucky Super Soft Anti Cavity

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 7.6mg in 1g
Labeler: Delta Brands Inc
NDC Code: 20276-554

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 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

LUCKY SUPER SOFT  ANTI CAVITY
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-554
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
POLYETHYLENE GLYCOL 400 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
SODIUM SILICATE 
SORBITOL 
SODIUM PYROPHOSPHATE 
TITANIUM DIOXIDE 
WATER 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:20276-554-012 TUBE in 1 BOX
1NDC:20276-554-04113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/31/2017
Labeler - Delta Brands Inc (102672008)

Revised: 07/2017
 
Delta Brands Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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