CREST- sodium fluoride paste, dentifrice 
Buzz Export Services Pty., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dental Kit - Crest Toothpaste

Drug Facts

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 yrs. of age.

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

Directions

Inactive Ingredients

water, sorbitol, hydrated silica, disodium pyrophosphate, xylitol, flavor, sodium hydroxide, cellulose gum, cocamidopropyl betaine, sodium laureth-2 phosphate, sodium saccharin, xanthan gum, carbomer, sucralose, polyethylene oxide, polyethylene, mica, titanium dioxide, blue 1 lake

Questions?

1-800-959-6586

Dist. by Procter & Gamble, Cincinnati, OH 45202

Package Labeling

crest24g

Kit Package:

kit package

CREST 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-831
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURETH-2 PHOSPHATE (UNII: 1IO8CC3XDG)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYETHYLENE OXIDE 900000 (UNII: 16P9295IIL)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-831-011 in 1 CARTON12/23/2014
124 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/23/2014
Labeler - Buzz Export Services Pty., Ltd. (747317902)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Baron Travel Product Co., Ltd.554520509repack(69491-831)

Revised: 5/2021
Document Id: 9ab12d8a-6144-5a7d-e053-2995a90a7c80
Set id: e05b59e4-6b4b-4c8d-965a-d5aa00345a08
Version: 4
Effective Time: 20210503
 
Buzz Export Services Pty., Ltd.