NATURES PROMISE CHILDRENS FLUORIDE STRAWBERRY- sodium monofluorophosphate paste, dentifrice

Natures Promise by

Drug Labeling and Warnings

Natures Promise by is a Otc medication manufactured, distributed, or labeled by Foodhold U.S.A., Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

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

SPL UNCLASSIFIED SECTION

Drug Facts

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 capped when not in use.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 1-877-846-6649

PRINCIPAL DISPLAY PANEL

Nature's Promise

children's fluoride toothpaste

strawberry

• protects against cavities
• tastes great
• helps fight tartar

NET WT 4.2 OZ (119 g)

INGREDIENTS AND APPEARANCE

NATURES PROMISE  CHILDRENS FLUORIDE STRAWBERRY
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-724
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: 41520-724-29	119 g in 1 TUBE; Type 0: Not a Combination Product	02/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/11/2019

Labeler - Foodhold U.S.A. (809183973)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(41520-724)