BRIGHT SMILES- sodium monofluorophosphate paste, 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 monofluorophosphate 0.76% (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 6 years of age: Do not use unless directed by a doctor or dentist

Inactive ingredients

calcium carbonate, water, sorbitol, 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 Toothpaste

NET WT. 1.5 oz (42g)

INGREDIENTS AND APPEARANCE

BRIGHT SMILES 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71074-108
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
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: 71074-108-37	17 g in 1 TUBE; Type 0: Not a Combination Product	05/15/2016
2	NDC: 71074-108-38	24 g in 1 TUBE; Type 0: Not a Combination Product	05/15/2016
3	NDC: 71074-108-39	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(71074-108)