TOMS FRESH AND BRIGHT- sodium monofluorophosphate paste, dentifrice

Toms Fresh and Bright by

Drug Labeling and Warnings

Toms Fresh and Bright by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc., Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% 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 dial (412) 390-3381 right away (Poison Control Center).

Directions

• adults and children 2 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 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask a dentist or physician

Inactive ingredients

water, sorbitol, hydrated silica, xylitol, glycerin, natural flavor, sodium lauryl sulfate, zinc citrate, xanthan gum, benzyl alcohol, carrageenan.

Questions?

1-800-FOR-TOMS (1-800-367-8667)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

Certified
B®
Corporation

NEW

THE ORIGINAL
Tom's
OF MAINE

NATURAL WITH FLUORIDE

FRESH +
BRIGHT
anticavity toothpaste

HELPS FIGHT BAD
BREATH BACTERIA

pureactiv:
SOLUTIONS

FRESH MINT

4.0 OZ (113 g)

INGREDIENTS AND APPEARANCE

TOMS FRESH AND BRIGHT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-919
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ZINC CITRATE (UNII: K72I3DEX9B)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARRAGEENAN (UNII: 5C69YCD2YJ)

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: 51009-919-40	1 in 1 CARTON	11/30/2021	12/30/2025
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 FINAL	part355	11/30/2021	12/30/2025

Labeler - Tom's of Maine, Inc. (052764354)

Registrant - Colgate-Palmolive Company (001344381)