HYVEE BRILLIANT WHITE- sodium fluoride paste, dentifrice 
HyVee 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 ingredients / Purpose

Sodium fluoride 0.243% ............Anticavity

Uses

Children under 2 years of age, consult a dentist or doctor

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

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.

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

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

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Carton label

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Tube Label

HYVEE  BRILLIANT WHITE
fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-197
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.243 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
MICA (UNII: V8A1AW0880)  
Product Characteristics
Color blue (light blue with sparkles) Score     
Shape Size
Flavor MINT (mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42507-197-79 1 in 1 CARTON
1 NDC:42507-197-72 164 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 01/20/2011
Labeler - HyVee Inc (006925671)
Registrant - Lornamead (126440440)
Establishment
Name Address ID/FEI Business Operations
Lornamead 126440440 manufacture(42507-197) , pack(42507-197)

Revised: 11/2012
Document Id: 93a14e19-feec-4c78-b84c-edea2bd2e71d
Set id: 823511d9-096b-486c-ab7c-5b6e8d536c92
Version: 1
Effective Time: 20121129
 
HyVee Inc