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  5. Label Information: Omni

FDA Label for Omni

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Omni Product Label

The following document was submitted to the FDA by the labeler of this product Solventum Us Opco Llc. 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.

Other



Drug Facts


Active Ingredient



Stannous fluoride 0.4% w/w (0.12% w/v fluoride ion)


Purpose



Anticavity


Use



Aids in the prevention of dental decay


Otc - Keep Out Of Reach Of Children



  • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
  • Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Directions



  • Adults and children 6 years of age and older: Use a pea-sized (.25g) dose once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

Other Information



  • Do not freeze or expose to extreme heat.
  • Do not use if tamper evident seal on top of box is broken or removed.

Inactive Ingredients



ascorbic acid, carbomer, citric acid, flavor, glycerin, triethanolamine


Questions Or Comments?



call toll free M-F 9am to 5pm EST/EDT at 1-800-634-2249


Package Label.Principal Display Panel



Mint

NDC 48878-4061-3

3M ESPE

OMNI Gel™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

Directions thoroughly.

Contents:

1 Bottle

NET WT. 4.3 oz (121.9 g)


* Please review the disclaimer below.