BRIGHT SMILES- sodium fluoride gel, dentifrice 
Brooke Supplies

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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Bright Smiles

Drug Facts

Active ingredient

Sodium Fluoride 0.22%
(0.1% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

aids in the prevention of dental cavities

Warning

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Inactive ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharin, sodium methyl paraben, sodium propyl paraben.

PRINCIPAL DISPLAY PANEL - 42 g Tube Label

BrightSmiles

Fluoride Gel Toothpaste

NET WT. 1.5 oz (42g)

PRINCIPAL DISPLAY PANEL - 42 g Tube Label
BRIGHT SMILES 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71074-109
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71074-109-417.9 g in 1 TUBE; Type 0: Not a Combination Product05/15/2016
2NDC:71074-109-4217 g in 1 TUBE; Type 0: Not a Combination Product05/15/2016
3NDC:71074-109-4324 g in 1 TUBE; Type 0: Not a Combination Product05/15/2016
4NDC:71074-109-4442 g in 1 TUBE; Type 0: Not a Combination Product05/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35505/15/2016
Labeler - Brooke Supplies (034574770)
Establishment
NameAddressID/FEIBusiness Operations
SKYLARK CMC PVT. LTD.650174824MANUFACTURE(71074-109)

Revised: 1/2017
Document Id: 399ab9a0-bbcc-49be-9af8-c7e7c2b5c4f0
Set id: dcf7a177-c353-4d4f-aab3-c58f574be11c
Version: 1
Effective Time: 20170127
 
Brooke Supplies