ORAL7 DRY MOUTH MOISTURIZING- sodium monofluorophosphate paste, dentifrice

Oral7 Dry Mouth Moisturizing by

Drug Labeling and Warnings

Oral7 Dry Mouth Moisturizing by is a Otc medication manufactured, distributed, or labeled by Oral7 USA Operations Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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).

Inactive ingredients

DICALCIUM PHOSPHATE, HYDROGENATED STARCH HYDROLYSATE, GLYCERIN, AQUA, SILICA, DEXTROSE MONOHYDRATE, HYDRATED SILICA, ISOCETETH-20, XYLITOL, SODIUM MONOFLUOROPHOSPHATE, XANTHAN GUM, MENTHA PIPERITA (PEPPERMINT OIL), SODIUM BENZOATE, LACTOPEROXIDASE, POTASSIUM THIOCYANATE, LACTOFERRIN, LYSOZYME, GLUCOSE OXIDASE, LIMONENE, CALCIUM LACTATE

Questions

or Comments? Tel.: +1 833-672-5787 weekdays or Email : info@oral7us.com / oral7us.com

Always follow the label

SPL UNCLASSIFIED SECTION

ORAL7

REAL DRY MOUTH RELIEF

TOOTHPASTE

Fluoride & Calcium

2.5 fl oz 75 ml (105g)

SUGAR FREE

Naturally Sweetened with Xylitol

Made in the EU

Oral7 International Pty. Ltd.

Suite 2, 15 Delawney Street

Balcatta, WA 6021 AUSTRALIA

USA & Canada

Oral7 U.S. (Op) Inc.info@oral7us.com

www.oral7us.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAL7 DRY MOUTH MOISTURIZING 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81175-000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
LACTOFERRIN, BOVINE (UNII: KG21X1090A)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (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)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MYELOPEROXIDASE (UNII: JQZ6YM58U5)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
POTASSIUM THIOCYANATE (UNII: TM7213864A)
LYSOZYME (UNII: 968JKA7T33)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
CALCIUM LACTATE (UNII: 2URQ2N32W3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81175-000-02	75 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/01/2019

Labeler - Oral7 USA Operations Inc (117789267)