LEVEL ANTICAVITY- sodium monofluorophosphate paste

Level Anticavity by

Drug Labeling and Warnings

Level Anticavity by is a Otc medication manufactured, distributed, or labeled by Level Oral Care, LLC , AmLion Toothpaste Mfg. Sdn. Bhd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:                                                                                     Purpose

Sodium monofluorophoshate 0.76 percent                                                 Anticaries

PURPOSE

Purpose
Anticaries

INDICATIONS & USAGE

Uses:

Aids in the prevention of dental cavities.

WARNINGS

Warnings:

Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach children under 6 years of age.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 2 years of age and older: Apply Level Toothpaste onto a soft bristle toothbrush. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Use a pea-sized amount. Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT

Inactive Ingredients: purified water, glycerin, sorbitol, xylitol hydrated silica, calcium carbonate,

tetrasodium pyrophosphate, sodium lauryl sulfate, sodium bicarbonate, sodium saccharin,

cellulose gum, sodium benzoate, flavor

DESCRIPTION

xylitol

Natural Enamel Protection

True Protection with fluoride

Gentle, yet powerful whitening agents

Ultimate freshness formula

Enamel Guard with pH stabilizers

Distributed by:
Level Oral Care, LLC
Jacksonville, FL 32246
www.leveloralcare.com
Product of MY

PRINCIPAL DISPLAY PANEL

Level

Mint Five

Anticavity Toothpaste

perfect your smile

NET WT 5.0 oz (141.7 g)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

DOSAGE FORMS & STRENGTHS

Level

Mint One

Anticavity Toothpaste

perfect your smile


NET WT 1.0 oz (28.3 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEVEL ANTICAVITY 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50001-111
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SACCHARIN (UNII: FST467XS7D)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50001-111-50	141.7 g in 1 TUBE
2	NDC: 50001-111-10	28.3 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part355	12/30/2009

Labeler - Level Oral Care, LLC (832019124)

Establishment
Name	Address	ID/FEI	Business Operations
AmLion Toothpaste Mfg. Sdn. Bhd.		652244161	manufacture