TARGET SENSITIVE WHITENING TP- sodium fluoride paste, dentifrice

Target Sensitive Whitening TP by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

PURPOSE

Antihypersensitivity

Anticavity

INDICATIONS & USAGE

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact * aids in the prevention of dental cavities

WARNINGS

When using this product, if irritation occurs discontinue use. Stop use and ask a doctor if * the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. * pain/sensitivity still persists after 4 weeks of use.

KEEP OUT OF REACH OF CHILDREN. If more than is used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush * brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. * children under 12 years of age: Consult a dentist or doctor.

OTHER SAFETY INFORMATION

store below 30C (86F)

INACTIVE INGREDIENT

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocomidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TARGET SENSITIVE WHITENING TP 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-237
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-237-79	1 in 1 CARTON	10/01/2024
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11673-237-89	1 in 1 CARTON	02/10/2024	02/24/2024
2		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	M022	02/01/2024

Labeler - Target (006961700)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(11673-237) , pack(11673-237)