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NDC 48878-4061-03 OMNI 0.969 mg/g Details

OMNI 0.969 mg/g

OMNI is a ORAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by 3M ESPE Dental Products. The primary component is STANNOUS FLUORIDE.

Product Information

NDC	48878-4061
Product ID	48878-4061_5539e66a-f111-4d1d-b4fd-6d0eaab84a84
Associated GPIs	88402030004010
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	OMNI
Proprietary Name Suffix	n/a
Non-Proprietary Name	stannous fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	ORAL
Active Ingredient Strength	0.969
Active Ingredient Units	mg/g
Substance Name	STANNOUS FLUORIDE
Labeler Name	3M ESPE Dental Products
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2024-12-31

Package

Package Images

NDC 48878-4061-03 (48878406103)

Pricing Information	N/A
NDC Package Code	48878-4061-3
Billing NDC	48878406103
Package	1 TUBE in 1 BOX (48878-4061-3) / 121.9 g in 1 TUBE
Marketing Start Date	1998-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0c2a81b1-65b5-432b-8e66-30432a245aba Details

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

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)

INGREDIENTS AND APPEARANCE

OMNI

stannous fluoride gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/01/1998

Labeler - 3M ESPE Dental Products (801390852)

Revised: 6/2019

Document Id: 5539e66a-f111-4d1d-b4fd-6d0eaab84a84

Set id: 0c2a81b1-65b5-432b-8e66-30432a245aba

Version: 5

Effective Time: 20190612