Oral7 Dry Mouth Moisturizing
FDA Label NDC 81175-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oral7 Usa Operations Inc for the product Oral7 Dry Mouth Moisturizing (NDC 81175-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, keep out of reach of children, do not use, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

* Please review the disclaimer below.