Omni Gel
FDA Label NDC 48878-4061

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Solventum Us Llc for the product Omni (NDC 48878-4061). 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, 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

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)

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