BRIGHT SMILES- sodium fluoride gel, dentifrice

Bright Smiles by

Drug Labeling and Warnings

Bright Smiles by is a Otc medication manufactured, distributed, or labeled by Brooke Supplies, SKYLARK CMC PVT. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

BRIGHT SMILES 
sodium fluoride gel, dentifrice

Product 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)