ENAMELON PREVENTIVE TREATMENT- stannous fluoride gel 
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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Active ingredient

Stannous fluoride 0.40% (0.15% w/v fluoride ion)

Purpose

Anticavity/Sensitivity Relief/Antigingivitis

Uses

Warnings

Keep out of the 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 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 6 years of age or 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 rinse, 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

This is an anticavity/fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. Products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Inactive ingredients

Acesulfame K, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, pva/ma copolymer, silica, sucralose

Questions or comments?

Call toll-free 1-888-670-6100 Monday-Friday 8am – 5pm EST

Distributed By

Premier® Dental Products Company, Plymouth Meeting, PA 19462

www.premusa.com 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!

ACPTM Enamel Therapy

Premier®

Enamelon Preventive Treatment Gel

Clean Mint

NET WT 4.0 OZ (113 g)

ULTRAMULSION®

premier Enamelon Preventive Treatment Gel Clean Mint 4.0 OZ (113 g)

ENAMELON PREVENTIVE TREATMENT 
stannous fluoride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:48783-500
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.00400 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) (UNII: 5216H1HX5F)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAUROYL SARCOSINE (UNII: LIJ19P3L6F)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color white Score     
Shape Size
Flavor MINT (Clean Mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:48783-500-40 1 in 1 CARTON
1 113 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/01/2014
Labeler - Premier Dental Products Company (014789663)
Establishment
Name Address ID/FEI Business Operations
Unicep Packaging, LLC 790263909 manufacture(48783-500) , pack(48783-500) , analysis(48783-500)

Revised: 7/2014
Document Id: 53f15ff7-8605-47c6-bb82-67d68efb015a
Set id: 04c3f178-7905-404d-9ac2-67c453287ddf
Version: 2
Effective Time: 20140710
 
Premier Dental Products Company