LUCKY SUPER SOFT WHITENING 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 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, calcium hydrogen phosphate, carboxymethyl cellulose, FDC Blue 1, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, sodium lauryl sulfate, sodium saccharin, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum

Package Label

Package Label

LUCKY SUPER SOFT  WHITENING ANTI CAVITY
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-553
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
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM SILICATE (UNII: IJF18F77L3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-553-012 in 1 BOX03/31/2017
1NDC:20276-553-04113 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: 7e185425-019e-6d6c-e053-2a91aa0aa696
Set id: 4d24da8e-1ea1-20ca-e054-00144ff88e88
Version: 4
Effective Time: 20181228
 
Delta Brands Inc