LUCKY SUPER SOFT SENSITIVE- sodium fluoride potassium nitrate 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

Potassium nitrate - 5%

Sodium fluoride - 0.24%

Purpose

Antihypersensitivity

Anticavity

Uses

■ builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact ■ aids in the prevention of dental cavities

Warnings

When using this product ■ if pain/sensitivity still persists after 4 weeks of use please visit your dentist

Stop and ask a dentist

■ if problem the persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children

If you accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately

Directions

adults and children 12 years and older brush teeth for at least one minute, preferably after each meal, or at least twice a day, or as directed by your dentist. Be sure to brush sensitive areas

children under 12 years of age consult a dentist or doctor.

Inactive ingredients

DC Yellow10, FDC Blue 1, flavor, glycerin, methylparaben, poly ethylene glycol 1500, propylparaben, silica, sodium benzoate, sodium carboxy methyl cellulose, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, treated water, tri sodium ortho phosphate

Package Label

Package Label

LUCKY SUPER SOFT  SENSITIVE
sodium fluoride potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-550
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-550-43122 g in 1 TUBE; Type 0: Not a Combination Product02/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/27/2014
Labeler - Delta Brands Inc (102672008)

Revised: 7/2017
Document Id: 53bbd4f8-22fe-09b5-e054-00144ff88e88
Set id: 4ec43b06-5b78-4a71-8dc4-11fbb03bb155
Version: 3
Effective Time: 20170707
 
Delta Brands Inc