HOME CARE FLUORIDE- stannous fluoride gel

Home Care Fluoride by

Drug Labeling and Warnings

Home Care Fluoride by is a Otc medication manufactured, distributed, or labeled by Dental Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Stannous Fluoride 0.4%

(0.12% w/v fluoride ion)

Purpose

Anticavity

Uses

Helps aid in the prevention of dental cavities.

Warnings

This is an anticavity fluoride preventive treatment gel, not a toothpaste.

Read directions carefully before using.

When using this product

it 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.

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.

Directions

• Adults and children 6 years of age and older: Use 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 use if the foil seal under the cap is torn, cut or missing.

Inactive ingredients

Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

Questions or comments?

1.800.835.0885 or 847.677.5500

Principal Display Panel

alpha-dent®

HOME CARE

FLUORIDE GEL

0.4% STANNOUS FLUORIDE

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

BUBBLE GUM

REF 004.0202.001

NET WEIGHT - 4.3 oz. (121.9g)

DENTAL

TECHNOLOGIES

6901 N HAMLIN AVENUE

LINCOLNWOOD, ILLINOIS 60712 USA

www.dentaltech.com

INGREDIENTS AND APPEARANCE

HOME CARE FLUORIDE 
stannous fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55346-0402
Route of Administration	ORAL, DENTAL

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 934 (UNII: Z135WT9208)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM (Bubble Gum)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55346-0402-1	121.9 g in 1 TUBE; Type 0: Not a Combination Product	12/31/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/31/1999

Labeler - Dental Technologies, Inc. (148312838)

Registrant - Dental Technologies, Inc. (148312838)

Establishment
Name	Address	ID/FEI	Business Operations
Dental Technologies, Inc.		148312838	manufacture(55346-0402) , label(55346-0402) , pack(55346-0402)