KMART CORPORATION RADIANT WHITE- 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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Kmart Radiant White

Active ingredient

Sodium fluoride 0.243% ..................................Purpose: Anticavity

Uses

aids in the prevention of dental caviites

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

Keep out of reach of children under 6 years of age.

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing). Supervise children as necessary until capable of using without supervision.

Other Information

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

Inactive ingredients

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, xanthan gum, carbomer, sodium saccharin, sodium hydroxide, mica, titanium dioxide, blue 1 lake, polyethylene

Adults and children 2 years of age and older: brush teeth throuoghly, preferably after every meal or at least twice a day, or as directed by a dentist or doctor.

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Carton label

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Tube Label

KMART CORPORATION  RADIANT WHITE
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-811
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Product Characteristics
Colorblue (Blue with flecks) Score    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-811-191 in 1 CARTON02/24/201502/21/2019
1NDC:49738-811-12113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/24/201402/21/2019
Labeler - KMart Corporation (008965873)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(49738-811)

Revised: 2/2019
 
KMart Corporation