LUCKY SUPER SOFT WHITENING ANTI CAVITY WITH FREE TOOTHBRUSH- 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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LuckyTthPsteNamnoflrophphte

Active Ingredient

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

Purpose

Anticavity

Uses

Regular brushing with fluoride tothpaste helps protect 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, FDC Blue 1, flavor, methyl paraben, polyethylene glycol 400, propyl paraben, sodium carboxy methyl cellulose, sodium lauryl sulphate, sodium saccharin, sodium silicate, sorbitol, precipitated silica, tetra sodium pyrophosphate, titanium dioxide, water

Package Label

Package Label

LUCKY SUPER SOFT  WHITENING ANTI CAVITY WITH FREE TOOTHBRUSH
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-552
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)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
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
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-552-64181 g in 1 TUBE; Type 1: Convenience Kit of Co-Package02/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/27/2014
Labeler - Delta Brands Inc (102672008)

Revised: 12/2020
Document Id: b673291e-14bd-9b86-e053-2a95a90a8339
Set id: 12495989-2e4e-41f1-b8e2-0b85aa96eea2
Version: 4
Effective Time: 20201214
 
Delta Brands Inc