OMNI- stannous fluoride gel 
Solventum US OpCo LLC

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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

Warnings

  • 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

Other information

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

Principle Display Panel

Mint

NDC 48878-4061-3

3M ESPE

OMNI Gel™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

Directions thoroughly.

Contents:

NET WT. 4.3 oz (121.9 g)

Principle Display Panel
OMNI 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-4061
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.969 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Glycerin (UNII: PDC6A3C0OX)  
Trolamine (UNII: 9O3K93S3TK)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48878-4061-31 in 1 BOX02/01/1998
1121.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02102/01/1998
Labeler - Solventum US OpCo LLC (801390852)

Revised: 4/2024
Document Id: 85fb2f58-d807-4570-93ad-fa5ea94ef23a
Set id: 0c2a81b1-65b5-432b-8e66-30432a245aba
Version: 6
Effective Time: 20240401
 
Solventum US OpCo LLC