WHITENING- monofluorophosphate paste, dentifrice

Whitening by

Drug Labeling and Warnings

Whitening by is a Otc medication manufactured, distributed, or labeled by Target, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium monofluorophosphate 0.76% w/w (0.14% w/v fluoride ion)

Purpose

Anticavity

Uses

aids in the prevention of dental cavities

Keep out of reach of children

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

Directions

adults and children 2 years of age and older: brush teeth thoroughly, preferably after ach meal or at least twice per day, or as directed by a dentist or doctor.

instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

supervise children as necessary until capable of using without supervision.

children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

glycerin, hydrated silica, water, sorbitol, pentasodium triphosphate, PVP, titanium dioxide, cellulose gum, flavor, cocamidopropyl betaine, sodium lauryl sulfate, potassium sorbate, sorbic acid, potassium acesulfam, sucralose, sodium hydroxide

Warnings

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

WHITENING 
monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-385
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-385-08	1 in 1 CARTON	02/10/2024
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	02/10/2024

Labeler - Target (006961700)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	pack(11673-385) , manufacture(11673-385)