KMART CORPORATION HEALTHY PROTECTION- fluoride paste, dentifrice 
Kmart Corporation

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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Smart Sense Healthy Protection

Active ingredient

Stannous fluoride 0.454% (0.16% w/v fluoride ion)............Anticavity, Antisensitivity

Uses

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

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. Stop use and ask a dentist if the sensitivity problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Brush teeth thoroughly for at least one minute, twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.

Do not swallow

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

water, hydrated silica, glycerin, propylene glycol, PEG-6, sodium tripolyphosphate, zinc lactate, trisodium phosphate, monosodium phosphate, flavor, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, polyethylene, xanthan

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Carton label

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Tube Label

KMART CORPORATION  HEALTHY PROTECTION
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-178
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.454 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ZINC LACTATE (UNII: 2GXR25858Y)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-178-891 in 1 CARTON12/01/201202/25/2019
1NDC:49738-178-82170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/201202/25/2019
Labeler - Kmart Corporation (008965873)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(49738-178)

Revised: 2/2019
 
Kmart Corporation