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OMNI

Dosage form: gel
Ingredients: stannous fluoride 4mg in 1g
Labeler: 3M ESPE Dental Products
NDC Code: 48878-4021

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Stannous fluoride 0.4% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental decay

Warnings

Keep out of reach of children. If more than used for brushing is accidentally swallowed, seek medical attention or contact a Poison Control Center right away.

  • this product may produce surface staining of the teeth
  • adequate toothbrushing may prevent staining
  • staining is not harmful or permanent and may be removed by your dental professional

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
  • this is a fluoride preventive treatment gel, not a toothpaste
  • read directions carefully before use
  • 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

glycerin, hydroxyethylcellulose, flavor

Questions or comments?

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

Principal Display Panel – Box Label

Grape

NDC 48878-4021-3

3M ESPE

OMNI Gel™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

1 Bottle

NET WT. 4.3 oz (121.9 g)

Principal Display Panel – Box Label

Raspberry

NDC 48878-4031-3

3M ESPE

OMNI Gel™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

1 Bottle

NET WT. 4.3 oz (121.9 g)

Principal Display Panel – Box Label

Cinnamon

NDC 48878-4041-3

3M ESPE

OMNI Gel™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

1 Bottle

NET WT. 4.3 oz (121.9 g)

Principal Display Panel – Box Label

Natural

NDC 48878-4051-3

3M ESPE

OMNI Gel™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

1 Bottle

NET WT. 4.3 oz (121.9 g)

Principal Display Panel – Box Label

Mint

NDC 48878-4061-3

3M ESPE

OMNI Gel™

0.4% Stannous Fluoride

Preventive Treatment Gel

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

1 Bottle

NET WT. 4.3 oz (121.9 g)

OMNI 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-4021
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
stannous fluoride (fluoride ion) stannous fluoride4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
hydroxyethyl cellulose (2000 cps at 1%) 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48878-4021-31 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
1121.9 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/1998
OMNI 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-4031
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
stannous fluoride (fluoride ion) stannous fluoride4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
hydroxyethyl cellulose (2000 cps at 1%) 
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRY (RASPBERRY) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48878-4031-31 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
1121.9 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/1998
OMNI 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-4041
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
stannous fluoride (fluoride ion) stannous fluoride4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
hydroxyethyl cellulose (2000 cps at 1%) 
Product Characteristics
Color    Score    
ShapeSize
FlavorCINNAMON (CINNAMON) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48878-4041-31 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
1121.9 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/1998
OMNI 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-4051
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
stannous fluoride (fluoride ion) stannous fluoride4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
hydroxyethyl cellulose (2000 cps at 1%) 
Packaging
#Item CodePackage Description
1NDC:48878-4051-31 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
1121.9 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/1998
OMNI 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-4061
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
stannous fluoride (fluoride ion) stannous fluoride4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glycerin 
hydroxyethyl cellulose (2000 cps at 1%) 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48878-4061-31 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
1121.9 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/1998
Labeler - 3M ESPE Dental Products (799975909)
Establishment
NameAddressID/FEIOperations
3M ESPE Dental Products799975909MANUFACTURE

Revised: 01/2010
 
3M ESPE Dental Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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