CARE ONE RESTORE AND DEFEND SENSITIVE WHITENING- stannous fluoride paste, dentifrice 
Foodhold U.S.A.

----------

5820293 Care One Restore & Defend Sensitive Whitening Toothpaste

Drug Facts

Active ingredient

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

Purpose

Anticavity/Antihypersensitivity

Uses

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.

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.

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 by your dentist.

This product is specifically formulated to help prevent staining.

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

Questions or Comments? CALL 1-877-846-9949

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

For product questions or concerns, contact us at 1-877-849-9949

CareOne®

RESTORE & DEFEND SENSITIVE TOOTHPASTE

FOR SENSITIVE TEETH & CAVITY PROTECTION

DAILY PROTECTION FOR SENSITIVE TEETH

WHITENING

FRESH MINT

NET WT 3.4 OZ (96.3 g)

CareOne_RestoreDefend_Carton_2821293R1

CARE ONE RESTORE AND DEFEND  SENSITIVE WHITENING
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-722
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-722-191 in 1 CARTON02/11/2019
196.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02102/11/2019
Labeler - Foodhold U.S.A. (809183973)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(41520-722)

Revised: 2/2024
Document Id: 1135ac41-1431-e9e2-e063-6394a90af727
Set id: 81a380eb-8605-b280-e053-2a91aa0abd4b
Version: 4
Effective Time: 20240212
 
Foodhold U.S.A.