OMNI- stannous fluoride gel

OMNI by

Drug Labeling and Warnings

OMNI by is a Otc medication manufactured, distributed, or labeled by Solventum US OpCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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

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)

INGREDIENTS AND APPEARANCE

OMNI 
stannous fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48878-4061
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
stannous fluoride (UNII: 3FTR44B32Q) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	0.969 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48878-4061-3	1 in 1 BOX	02/01/1998
1		121.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/01/1998

Labeler - 3M ESPE Dental Products (801390852)