KMART CORPORATION HEALTHY PROTECTION- stannous 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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Drug Facts

Active ingredient

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

Uses

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49738-178
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.4540 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
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     
Shape Size
Flavor MINT (mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49738-178-89 1 in 1 CARTON
1 NDC:49738-178-82 170 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 12/01/2012
Labeler - Kmart Corporation (008965873)
Registrant - Lornamead (126440440)
Establishment
Name Address ID/FEI Business Operations
Lornamead 126440440 manufacture(49738-178) , pack(49738-178)

Revised: 1/2013
Document Id: b030f080-38bf-437c-9b41-0a11ba59854f
Set id: 593e4b44-6630-4339-8ad5-a545ebceda7d
Version: 1
Effective Time: 20130108
 
Kmart Corporation