Your browser does not support JavaScript! HEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]
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RxNorm Names

HEB BRILLIANT WHITE (fluoride) paste, dentifrice
[HEB]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Sodium Monofluorophosphate 0.76% w/w (0.15% w/v fluoride ion)..................................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

glycerin, dicalcium phosphate, PEG-12, PVP, PEG/PPG 116/66 copolymer, hydrated silica, hydrogen peroxide, propylene glycol, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water

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

HEB  BRILLIANT WHITE
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37808-896
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
SODIUM PYROPHOSPHATE 
POLYETHYLENE GLYCOL 600 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
SUCRALOSE 
BUTYLATED HYDROXYTOLUENE 
PEG/PPG-116/66 COPOLYMER 
PHOSPHORIC ACID 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYDRATED SILICA 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (L Menthol) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-896-691 in 1 CARTON
1NDC:37808-896-62156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/01/2012
Labeler - HEB (007924756)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(37808-896), pack(37808-896)

Revised: 11/2012
 
HEB

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