SIMPLE TRUTH KIDS FLOURIDE- sodium monofluorophosphate paste, dentifrice

Simple Truth by

Drug Labeling and Warnings

Simple Truth by is a Otc medication manufactured, distributed, or labeled by Kroger Company, Lornamead, Inc., Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use

Helps protect against cavities

WARNINGS

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

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years: use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

​Children under 2 years of age: consult a dentist or physician.

INACTIVE INGREDIENT

Inactive ingredients Glycerin, Water, Calcium Carbonate, Hydrated Silica, Natural Flavor, Carrageenan, Sodium Lauroyl Sarcosinate

STORAGE AND HANDLING

Other information

Store in a cool dry place. Keep tube covered when not in use.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL

simple truth

KIDS' Fluoride Toothpaste

PREVENTS CAVITIES

STRAWBERRY

no artificial colors, preservatives, flavors or sweeteners

4.2 OZ (119g)

INGREDIENTS AND APPEARANCE

SIMPLE TRUTH   KIDS FLOURIDE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-146
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARRAGEENAN (UNII: 5C69YCD2YJ)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-146-79	119 g in 1 TUBE; Type 0: Not a Combination Product	02/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/25/2019

Labeler - Kroger Company (006999528)

Registrant - Lornamead, Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(30142-146)