ORAL7- sodium monofluorophosphate paste

Oral7 by

Drug Labeling and Warnings

Oral7 by is a Otc medication manufactured, distributed, or labeled by JCEC Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sodium Monofluorophosphate 0.76% w/w (1000ppmF)

Purpose

Anti-cavity

Use

Aids in the prevention of dental 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 contact a Poison Control Center right away. If symptoms of dry mouth persist, consult a health care professional.

DO NOT use if you are allergic to any of the ingredients.

Directions

Adults and Children 2 years of age and older

• Use 2-3 times a day, 7 days a week.
• Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist
• Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

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

Other Information

Store below 77°F (25°C).

Ingredients

Sorbitol, Dicalcium Phosphate, Glycerin, Hydrated Silica, Dextrose Monohydrate, Silica, Isoceteth-20, Xylitol, Water, Cellulose Gum, Sodium Benzoate, Lactoperoxidase , Mentha Piperita (Peppermint Oil-includes limonene), Potassium Thiocyanate, Menthol, Lactoferrin , Lysozyme, Glucose Oxidase, Calcium Lactate

Questions or Comments?

Call Tel. : 908-420-3759 weekdays or, email us: info@fountainhealthcarellc.com

PRINCIPAL DISPLAY PANEL - 105 g Tube Carton

NDC: 69297-000-19

Oral 7®Xylitol
balancing your mouth's natural flora

Beneficial for the
whole family!

✓ No SLS (harsh drying detergent)

✓ With Fluoride & Calcium

✓ Extra Beneficial for Dry Mouth

MOISTURIZING
TOOTHPASTE

With natural enzymes to
help reinforce your
mouth's own defense system

75mL (105g) e

INGREDIENTS AND APPEARANCE

ORAL7 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69297-000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOCETETH-20 (UNII: O020065R7Z)
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MYELOPEROXIDASE (UNII: JQZ6YM58U5)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
POTASSIUM THIOCYANATE (UNII: TM7213864A)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
LACTOFERRIN, BOVINE (UNII: KG21X1090A)
LYSOZYME (UNII: 968JKA7T33)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
CALCIUM LACTATE (UNII: 2URQ2N32W3)

Product Characteristics
Color	WHITE (TO OFF WHITE)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69297-000-19	1 in 1 CARTON
1		105 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	02/01/2015

Labeler - JCEC Company, Inc. (961973299)