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

CO Oh So Dazzling Sweet Mint by

Drug Labeling and Warnings

CO Oh So Dazzling Sweet Mint by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Colgate Palmolive Manufacturing (Poland) Sp. z o.o.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

DOSAGE & ADMINISTRATION

• adults and children 6 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
• children 6 to 12 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 6 years: do 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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

CO OH SO DAZZLING SWEET MINT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-135
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-135-69	1 in 1 CARTON	11/01/2020	06/30/2024
1		113 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 DRUG	M021	11/01/2020	06/30/2024

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate Palmolive Manufacturing (Poland) Sp. z o.o.		524937331	ANALYSIS(35000-135) , LABEL(35000-135) , MANUFACTURE(35000-135) , PACK(35000-135)