CVS RESTORE AND DEFEND SENSITIVE WHITENING- stannous fluoride paste, dentifrice

CVS Restore and Defend Sensitive by

Drug Labeling and Warnings

CVS Restore and Defend Sensitive by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

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

PURPOSE

Purpose

Anticavity / Antihypersensitivity

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

When using this product, if irritation occurs discontinue use.

Stop use 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/sensitivity still persists after 4 weeks of use

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 meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.
• Do not swallow
• Children under 12 years of age: consult a dentist or doctor

STORAGE AND HANDLING

Other information

• products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed your dentist.
• This product is specifically formulated to help prevent staining
• store below 30°C (86°F)

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

©2019 CVS/pharmacy

CVS.com

1-800-SHOP CVS

PRINCIPAL DISPLAY PANEL

CVS Health™

RESTORE & DEFEND

SENSITIVE ANTICAVITY TOOTHPASTE WITH FLUORIDE

For sensitive teeth & cavity protection

Whitening

Fresh Mint

NET WT 3.4 OZ (96.4 g)

INGREDIENTS AND APPEARANCE

CVS RESTORE AND DEFEND SENSITIVE  WHITENING
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-218
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.454 g  in 100 g

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

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-218-19	1 in 1 CARTON	02/11/2019
1		96.4 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 not final	part356	02/11/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(69842-218)