Oral7
FDA Label NDC 69297-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jcec Company, Inc. for the product Oral7 (NDC 69297-000). 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 other, active ingredient, purpose, use, otc - keep out of reach of children, otc - do not use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Sodium Monofluorophosphate 0.76% w/w (1000ppmF)

Purpose

Anti-cavity

Use

Aids in the prevention of dental cavities.

Otc - Keep Out Of Reach Of Children

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.

Otc - Do Not Use

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

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

    Principal Display Panel (105 g Tube Carton)

    Principal Display Panel (105 g Tube Carton)

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