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OMNI

3M ESPE Dental Products


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 Type Human otc drug label Item Code (Source) NDC:48878-4021
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 4 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 121.9 in 1 BOTTLE, PLASTIC
2 NDC:48878-4021-3 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1998-02-01


OMNI

stannous fluoride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48878-4031
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 4 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 121.9 in 1 BOTTLE, PLASTIC
2 NDC:48878-4031-3 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1998-02-01


OMNI

stannous fluoride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48878-4041
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 4 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 121.9 in 1 BOTTLE, PLASTIC
2 NDC:48878-4041-3 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1998-02-01


OMNI

stannous fluoride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48878-4051
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 4 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 121.9 in 1 BOTTLE, PLASTIC
2 NDC:48878-4051-3 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1998-02-01


OMNI

stannous fluoride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48878-4061
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 4 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 121.9 in 1 BOTTLE, PLASTIC
2 NDC:48878-4061-3 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1998-02-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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