ALPHA-DENT HOME CARE FLUORIDE - stannous fluoride gel 
Dental Technologies, Inc.

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.

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Active Ingredient

Stannous Fluoride 0.4%

Purpose

Anticavity

Uses

Helps aid in the prevention of dental cavities.

Warnings

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

Read directions carefully before using.

This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful to 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.

Do not use

if inner foil is torn, cut or missing.

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.

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

STRAWBERRY

REF 004-0401-001

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

ADA ACCEPTED

AMERICAN DENTAL ASSOCIATION

NET WEIGHT - 4.3 oz. (121.9g)

DENTAL

TECHNOLOGIES

6901 N HAMLIN AVENUE

LINCOLNWOOD, ILLINOIS 60712 USA

www.dentaltech.com

image of carton


ALPHA-DENT  HOME CARE FLUORIDE
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-0404
Route of AdministrationDENTAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (FLUORIDE ION) Stannous Fluoride4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
CARBOMER 934 
Ascorbic Acid 
Citric Acid Monohydrate 
Trolamine 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (Strawberry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55346-0404-1121.9 g in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/31/1999

Labeler - Dental Technologies, Inc. (148312838)
Registrant - Dental Technologies, Inc. (148312838)
Establishment
NameAddressID/FEIOperations
Dental Technologies, Inc.148312838manufacture, label, pack

Revised: 09/2012 Dental Technologies, Inc.