NATURAL PREBIOTIC PEPPERMINT PPBT4- sodium fluoride paste, dentifrice NATURAL PREBIOTIC SPEARMINT SPBT4- sodium fluoride paste, dentifrice

Natural Prebiotic Spearmint SPBT4 by

Drug Labeling and Warnings

Natural Prebiotic Spearmint SPBT4 by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drugs Facts

Active ingredient

Sodium fluoride 0.24 % (0.15% 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, glycerin, xylitol, inulin, sodium lauryl sulfate, zinc citrate, natural flavor, xanthan gum, benzyl alcohol, carrageenan.

Questions?

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

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DIST. BY TOM'S OF MAINE, INC., KENNEBUNK, ME 04043 U.S.A.

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Peppermint

new

SINCE 1970
Tom's
OF MAINE®

PREBIOTIC
FLUORIDE TOOTHPASTE

HELPS SUPPORT GOOD BACTERIA
TO MAINTAIN HEALTHY BALANCE*

• fights cavities
• whitens teeth
• strengthens enamel
• fights tartar buildup
• freshens breath

PEPPERMINT

4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Spearmint

new

SINCE 1970
Tom's
OF MAINE®

NATURAL
PREBIOTIC
FLUORIDE TOOTHPASTE

HELPS SUPPORT GOOD BACTERIA
TO MAINTAIN HEALTHY BALANCE*

• fights cavities
• whitens teeth
• strengthens enamel
• fights tartar buildup
• freshens breath

SPEARMINT

4 OZ (113 g)

INGREDIENTS AND APPEARANCE

NATURAL PREBIOTIC PEPPERMINT PPBT4 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-903
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.0015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Zinc Citrate (UNII: K72I3DEX9B)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Xanthan Gum (UNII: TTV12P4NEE)
Carrageenan (UNII: 5C69YCD2YJ)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Sorbitol (UNII: 506T60A25R)
Benzyl Alcohol (UNII: LKG8494WBH)
Inulin (UNII: JOS53KRJ01)
Peppermint (UNII: V95R5KMY2B)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-903-04	1 in 1 CARTON	11/29/2019
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	11/29/2019

NATURAL PREBIOTIC SPEARMINT SPBT4 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-904
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.0015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Zinc Citrate (UNII: K72I3DEX9B)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Xanthan Gum (UNII: TTV12P4NEE)
Carrageenan (UNII: 5C69YCD2YJ)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Sorbitol (UNII: 506T60A25R)
Benzyl Alcohol (UNII: LKG8494WBH)
Inulin (UNII: JOS53KRJ01)
Spearmint (UNII: J7I2T6IV1N)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	SPEARMINT (Spearmint Ice)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-904-04	1 in 1 CARTON	11/29/2019
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	11/29/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-903, 51009-904)