Label: BRIGHT SMILES- sodium fluoride gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 71074-109-41, 71074-109-42, 71074-109-43, 71074-109-44 - Packager: Brooke Supplies
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 27, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warning
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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
- PRINCIPAL DISPLAY PANEL - 42 g Tube Label
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INGREDIENTS AND APPEARANCE
BRIGHT SMILES
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71074-109 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71074-109-41 7.9 g in 1 TUBE; Type 0: Not a Combination Product 05/15/2016 2 NDC:71074-109-42 17 g in 1 TUBE; Type 0: Not a Combination Product 05/15/2016 3 NDC:71074-109-43 24 g in 1 TUBE; Type 0: Not a Combination Product 05/15/2016 4 NDC:71074-109-44 42 g in 1 TUBE; Type 0: Not a Combination Product 05/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 05/15/2016 Labeler - Brooke Supplies (034574770) Establishment Name Address ID/FEI Business Operations SKYLARK CMC PVT. LTD. 650174824 MANUFACTURE(71074-109)
