HEB  BRILLIANT WHITE- fluoride paste, dentifrice 
HEB

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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HEB Brilliant White Dazzling Mint

Drug Facts

Active ingredient

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

Purpose

Anticavity

Uses aids in the prevention of dental caviites

Warnings

Keep out of reach of children under 6 years of age. 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 per day, or as directed by a dentist or doctor.

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

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

Questions or comments? CALL 1-877-777-2743

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

H-E-B®

Dazzling Mint

BRILLIANT WHITE

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT. 5 OZ (141.7 g)

HEB BRILLIANT WHITE 2821228R3

HEB   BRILLIANT WHITE
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-896
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ETIDRONIC ACID (UNII: M2F465ROXU)  
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
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 CARTON10/01/201202/21/2019
1156 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:37808-896-291 in 1 CARTON02/21/2019
2141.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/01/2012
Labeler - HEB (007924756)
Registrant - Lornamead Inc. (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.080046418manufacture(37808-896)

Revised: 1/2023
Document Id: f2041946-915c-7b8c-e053-2a95a90a22fb
Set id: 681dd1e8-e00b-4e56-b950-04976203513c
Version: 10
Effective Time: 20230111
 
HEB