LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY- potassium nitrate, sodium monofluorophosphate paste

LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY by

Drug Labeling and Warnings

LEVEL HERBAL MINT FIVE SENSITIVE FORMULA 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

DRUG FACTS

Active Ingredient                                        Purpose

Potassium Nitrate 5%                               Antihypersensitivity

Sodium Monofluorophosphate 0.76%....Anticaries

PURPOSE

Purpose:
Antihypersensitivity and Anticaries

INDICATIONS & USAGE

Uses:

Builds increasing protection against painful sensitivity of the teeth due to cold, heat acids, sweets, or contact

Aids in the prevention of dental cavities.

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 of children under 6 years of age.

DOSAGE & ADMINISTRATION

DIRECTIONS

Adults and children 2 years of age and older:

Apply Level Toothpaste on to a soft bristle toothbrush. Brush 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

Dicalcium Phosphate Dihydrate, Purified WAter, Xylitol, Glycerin, Hydrated Silica, Sorbitol, Carboxy Methyl Cellulose, Sodium Lauryl sulfate, Flavor, Tetrasodium Pyrophosphate, Sodium Bicarbonate, Sodium Benzoate, Sodium Saccharin

SPL UNCLASSIFIED SECTION

Xylitol

Natural Enamel protection

True protection with fluoride

Advanced pain-blocking technology

Soothing herbal mint

enamel guard with pH stabilizers

Distributed by

level oral care, LLC

Jacksonville, FL 32246

www.leveloralcare.com

Product of MY

PRINCIPAL DISPLAY PANEL

Level

Herbal Mint Five

Sensitive Formula

Anticavity Toothpaste

perfect your smile

NET WT. 5.0 OZ (141.7G)

Xylitol

natural enamel protection

True protection with fluoride

Advanced pain-blocking technology

Soothing herbal mint

Enamel Guard with pH stabilizers

ACTIVE INGREDIENT:

Potassium nitrate 5%

Sodium monofluorophosphate 0.76%

USES:

Builds increasing protection against painful sensitivity of the teeth due to cold heat acids, sweets or contact. Aids in the prevention of dental cavities

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. Instruct children under 6 years of age 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

WARNINGS

Keep out of reach of children under 6 years of age. Do not swallow. if more than used from brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Distributed by:

Level Oral Care, LLC
Jacksonville, FL 32246
www.leveloralcare.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY 
potassium nitrate, sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50001-131
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50001-131-50	141.7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part356	08/12/2010

Labeler - LEVEL ORAL CARE, LLC (832019124)

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