PEPPERMINT CHARCOAL ANTICAVITY PCFT6 GENTLY WHITENS TEETH / FIGHTS CAVITIES / SAFE FOR ENAMEL / SAFE FOR EVERYDAY USE- sodium fluoride paste, dentifrice

Peppermint Charcoal Anticavity PCFT6 by

Drug Labeling and Warnings

Peppermint Charcoal Anticavity PCFT6 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

Drug 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

hydrated silica, water, sorbitol, glycerin, xylitol, lauryl glucoside, sodium cocoyl glutamate, natural flavor1, benzyl alcohol, charcoal powder, xanthan gum, carrageenan, Rebaudioside A.

1 peppermint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

SINCE 1970
Tom's®
OF MAINE

natural
with fluoride | sls-free

ACTIVATED CHARCOAL

anticavity toothpaste

gently whitens teeth | fights cavities
safe for enamel | safe for everyday use

peppermint

with
plant-based
activated
charcoal

4.7 OZ (133 g)

INGREDIENTS AND APPEARANCE

PEPPERMINT CHARCOAL ANTICAVITY PCFT6   GENTLY WHITENS TEETH / FIGHTS CAVITIES / SAFE FOR ENAMEL / SAFE FOR EVERYDAY USE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-900
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	0.0024 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Hydrated Silica (UNII: Y6O7T4G8P9)
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Xylitol (UNII: VCQ006KQ1E)
Lauryl Glucoside (UNII: 76LN7P7UCU)
Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG)
Peppermint Oil (UNII: AV092KU4JH)
Benzyl Alcohol (UNII: LKG8494WBH)
Activated Charcoal (UNII: 2P3VWU3H10)
Xanthan Gum (UNII: TTV12P4NEE)
Carrageenan (UNII: 5C69YCD2YJ)
Rebaudioside A (UNII: B3FUD0528F)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-900-47	1 in 1 CARTON	12/18/2018
1		133 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51009-900-01	1 in 1 CARTON	11/15/2019
2		0.75 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 51009-900-10	0.75 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/18/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-900)