CO OH SO DAZZLING SWEET MINT- sodium monofluorophosphate paste, dentifrice 
Colgate-Palmolive Company

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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CO Oh So Dazzling Sweet Mint

Drug Facts

Active ingredient

Sodium Monofluorophosphate 1.14% (0.20% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 6 to 12 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 6 yearsdo not use unless directed by a dentist or physician

Inactive ingredients

Poloxamer 105, Calcium Pyrophosphate, Triacetin, PEG-12, PVP, PEG/PPG-116/66 Copolymer, Tetrasodium Pyrophosphate, Silica, Flavor, Betaine, Sodium Lauryl Sulfate, Sodium Saccharin, Hydrogen Peroxide, Sucralose, Carboxylesterase, Maltodextrin, BHT.

Questions?

1-855-658-0289

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

CO.
Colgate

Oh So
Dazzling
Toothpaste

Sweet Mint

Effortless Whitening

Hydrogen Peroxide +
Enzyme Technology

Anticavity Toothpaste
NET WT 4.0 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
CO OH SO DAZZLING SWEET MINT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-135
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLOXAMER 105 (UNII: XPP85ZHV76)  
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
TRIACETIN (UNII: XHX3C3X673)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BETAINE (UNII: 3SCV180C9W)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
COCAINE ESTERASE (UNII: RP76COW7LH)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-135-691 in 1 CARTON11/01/2020
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/01/2020
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate Palmolive Manufacturing (Poland) Sp. z o.o.524937331ANALYSIS(35000-135) , LABEL(35000-135) , MANUFACTURE(35000-135) , PACK(35000-135)

Revised: 10/2020
Document Id: 682a4b76-b38a-4528-96dd-cb07e1f8510e
Set id: 869b71ad-56dc-4fd3-b849-12a94241960b
Version: 10
Effective Time: 20201029
 
Colgate-Palmolive Company