RESTORE AND DEFEND WHITENING TP- stannous fluoride paste, dentifrice

Restore and Defend Whitening TP by

Drug Labeling and Warnings

Restore and Defend Whitening TP by is a Otc medication manufactured, distributed, or labeled by Kroger, Lornamead, Lornamead, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

INACTIVE INGREDIENT

glycerin, water, hydrated silica, pentasodium triphosphate, cellulose gum, cocamidopropyl betaine, flavor, sodium lauryl sulfate, titanium dioxide, sodium saccharin

PURPOSE

Anticavity, Antihypersensitivity

INDICATIONS & USAGE

aids in the prevention of dental cavities

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

WARNINGS

When using this product, if irritation occurs discontinue use.

Stop using and ask a dentist if:

- the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist

- pain/sensitivty still persists after 4 weeks of use

Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions 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, preferably after each emal or at least twice a day (morning and evening) or as recommended by a dentist or physician.

Make sure to brush all sensitive areas of the teeth. Do not swallow. children under 12 years of age: Consult a dentist or doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RESTORE AND DEFEND WHITENING TP 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-256
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (White to white with Sl yellow hue)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-256-01	1 in 1 CARTON	12/18/2024
1		96 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	12/18/2024

Labeler - Kroger (006999528)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead, Inc		080046418	manufacture(30142-256) , pack(30142-256)