Your browser does not support JavaScript! ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]
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ENAMELON PREVENTIVE TREATMENT (stannous fluoride) gel
[Premier Dental Products Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

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

Purpose

Anticavity/Sensitivity Relief/Antigingivitis

Uses

  • Aids in the prevention of caries
  • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • Helps prevent gingivitis
  • Helps interfere with the harmful effects of plaque associated with gingivitis

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.

  • Do not use if foil seal is broken or missing
  • Keep tightly closed when not in use
  • Store at controlled room temperature

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:48783-500
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION0.00400 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CALCIUM SULFATE 
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) 
COCAMIDOPROPYL BETAINE 
DIMETHICONE 
GLYCERIN 
LAUROYL SARCOSINE 
SODIUM PHOSPHATE, MONOBASIC 
POLOXAMER 407 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
SUCRALOSE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48783-500-401 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2014
Labeler - Premier Dental Products Company (014789663)
Establishment
NameAddressID/FEIBusiness Operations
Unicep Packaging, LLC790263909manufacture(48783-500), pack(48783-500), analysis(48783-500)

Revised: 7/2014
 
Premier Dental Products Company

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