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Bright Smiles by Brooke Supplies

Medically reviewed on Jan 27, 2017

Dosage form: gel, dentifrice
Ingredients: Sodium Fluoride 0.1g in 100g
Labeler: Brooke Supplies
NDC Code: 71074-109

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.

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
  • do not swallow
  • supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
  • Children under 2 years of age: Consult a dentist doctor.

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)

BRIGHT SMILES 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71074-109
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
SACCHARIN SODIUM 
METHYLPARABEN SODIUM 
PROPYLPARABEN SODIUM 
Packaging
#Item CodePackage Description
1NDC:71074-109-417.9 g in 1 TUBE
2NDC:71074-109-4217 g in 1 TUBE
3NDC:71074-109-4324 g in 1 TUBE
4NDC:71074-109-4442 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35505/15/2016
Labeler - Brooke Supplies (034574770)
Establishment
NameAddressID/FEIOperations
SKYLARK CMC PVT. LTD.650174824MANUFACTURE(71074-109)

 
Brooke Supplies

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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