SEA SALT ANTICAVITY SALT47 GENTLY SCRUBS AWAY SURFACE STAINS / FIGHTS BAD BREATH GERMS / STRENGTHENS ENAMEL- sodium fluoride paste, dentifrice

Sea Salt Anticavity SALT47 by

Drug Labeling and Warnings

Sea Salt Anticavity SALT47 by is a Otc medication manufactured, distributed, or labeled by Toms 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

water, sorbitol, hydrated silica, xylitol, glycerin, sodium chloride, sodium lauryl sulfate, zinc citrate, natural flavor1, xanthan gum, carrageenan.

1 peppermint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

4.7 OZ (133 g)

SINCE 1970
Tom's®
OF MAINE

natural
with fluoride

SEA SALT

anticavity toothpaste

gently scrubs away surface stains
fights bad breath germs
strengthens enamel

refreshing mint

with
purified
sea salt

INGREDIENTS AND APPEARANCE

SEA SALT ANTICAVITY SALT47   GENTLY SCRUBS AWAY SURFACE STAINS / FIGHTS BAD BREATH GERMS / STRENGTHENS ENAMEL
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-901
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
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Xylitol (UNII: VCQ006KQ1E)
Glycerin (UNII: PDC6A3C0OX)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Zinc Citrate (UNII: K72I3DEX9B)
Peppermint Oil (UNII: AV092KU4JH)
Xanthan Gum (UNII: TTV12P4NEE)
Carrageenan (UNII: 5C69YCD2YJ)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	PEPPERMINT (Refreshing Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-901-47	1 in 1 CARTON	11/12/2018
1		133 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	11/12/2018

Labeler - Toms of Maine, Inc. (052764354)

Establishment
Name	Address	ID/FEI	Business Operations
Toms of Maine, Inc.		829517189	MANUFACTURE(51009-901)