ORAL7 DRY MOUTH MOISTURIZING- sodium monofluorophosphate paste, dentifrice 
Oral7 USA Operations Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Oral7 Dry Mouth Moisturizing Toothpaste

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

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

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

box

label

ORAL7 DRY MOUTH MOISTURIZING 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81175-000
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81175-000-0275 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2019
Labeler - Oral7 USA Operations Inc (117789267)

Revised: 6/2021
Document Id: c4bd3ffa-9a36-894e-e053-2995a90a2c95
Set id: c4bd3ffa-9a35-894e-e053-2995a90a2c95
Version: 1
Effective Time: 20210614
 
Oral7 USA Operations Inc