FDA Label for Oral7 Dry Mouth Moisturizing
View Indications, Usage & Precautions
Oral7 Dry Mouth Moisturizing Product Label
The following document was submitted to the FDA by the labeler of this product Oral7 Usa Operations Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Sodium Monofluorophosphate 0.76% w/w (1000ppmF)
Purpose
Anti-cavity
Use
Aids in the prevention of dental cavities.
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 : [email protected] / oral7us.com
Always follow the label
Other
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) [email protected]
www.oral7us.com
Package Label.Principal Display Panel
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