ENAMELON- stannous fluoride paste, dentifrice 
Premier Dental Products Company

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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Enamelon Paste

Active ingredient

Stannous fluoride 0.45% (0.16% w/v fluoride ion)

Purpose

Anticavity/Sensitivity Relief/Antigingivitis

Uses

Warnings

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks, see your dentist. See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Stop use and ask a dentist if the problem persists or worsens. Do not use this product for sensitivity relief longer than 4 weeks unless recommended by a dentist or doctor.

Directions

Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Other information

Inactive ingredients

Glycerin, polyethylene glycol, silica, calcium/sodium maleate methyl vinyl ether copolymer, cocamidopropyl betaine, calcium sulfate, poloxamer 407, dimethicone, lauroyl-sarcosine, titanium dioxide, flavor, acesulfame k, monosodium phosphate, sucralose

Questions or comments?

Call toll-free 1-888-670-6100

Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST

Distributed By

Premier ® Dental Products Company, Plymouth Meeting, PA 19462

www.premusa.com Part # 9007280 www.enamelon.com

United States Patent Numbers : US 5,993,784, US 5,711,936, US 5,651,959 and other patents pending. Made in U.S.A.

Ultramulsion ® is a registered trademark of WhiteHill Oral Technologies, Inc.

PRINCIPAL DISPLAY PANEL

STRENGTHEN YOUR SMILE!

ACP TM Enamel Therapy

Premier ®

Enamelon ®

Mint Breeze

Fluoride Toothpaste NET WT 4.3 OZ (122 g)

For Anticavity, Antigingivitis & Sensitive Teeth

HYDRAMULSION ®

NDC 48783-520-43 Enamelon Toothpaste Box

ENAMELON 
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48783-520
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.00454 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) (UNII: 5216H1HX5F)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LAUROYL SARCOSINE (UNII: LIJ19P3L6F)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Mint Breeze) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48783-520-431 in 1 CARTON01/01/2014
1122 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:48783-520-081 in 1 CARTON01/01/2014
221.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2014
Labeler - Premier Dental Products Company (014789663)

Revised: 1/2023
Document Id: e07b44db-7c5b-34fe-e053-2a95a90a4d3c
Set id: 1626375a-f78b-4192-b7f3-ca932acab7fb
Version: 5
Effective Time: 20230104
 
Premier Dental Products Company