Cvs Restore And Defend Sensitive Whitening (Stannous Fluoride) Paste, Dentifrice [Cvs Pharmacy] -

CVS RESTORE AND DEFEND SENSITIVE WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]
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NDC	69842-218-19
Set ID	81b72da2-7f41-74ca-e053-2a91aa0a9646
Category	HUMAN OTC DRUG LABEL
Packager	CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number	PART356

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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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/11/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead Inc. (080046418)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead Inc.		080046418	manufacture(69842-218)

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Medic

CVS RESTORE AND DEFEND SENSITIVE WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]

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