Your browser does not support JavaScript! ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]
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ENAMELON (stannous fluoride) paste, dentifrice
[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 0.45% (0.16% 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 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

  • 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 on tube is broken or missing
  • Keep tightly closed when not in use
  • Store at controlled room temperature

Inactive ingredients

Glycerin, polyethylene glycol, silica, pvm/ma copolymer, cocamidopropyl betaine, calcium sulfate, poloxamer 407, dimethicone, lauroyl-sarcosine, TiO2, flavor, acesulfame k, monosodium phosphate, 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 Fluoride Toothpaste

For Anticavity, Antigingivitis & Sensitive Teeth

Mint Breeze

NET WT 4.3 OZ (122 g)

ULTRAMULSION®

NDC 48783-520-43

premier Enamelon Fluoride Toothpaste Mint Breeze 4.3 OZ (122 g)

STRENGTHEN YOUR SMILE!

ACPTM Enamel Therapy

Premier®

Enamelon Fluoride Toothpaste

For Anticavity, Antigingivitis & Sensitive Teeth

Mint Breeze

NET WT 0.75 OZ (21.2 g)

ULTRAMULSION®

NDC 48783-520-08

premier Enamelon Fluoride Toothpaste Mint Breeze 0.75 OZ (21.2 g)

ENAMELON 
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:48783-520
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION0.00454 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) 
COCAMIDOPROPYL BETAINE 
CALCIUM SULFATE 
POLOXAMER 407 
DIMETHICONE 
LAUROYL SARCOSINE 
TITANIUM DIOXIDE 
ACESULFAME POTASSIUM 
SODIUM PHOSPHATE, MONOBASIC 
SUCRALOSE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Mint Breeze) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48783-520-431 in 1 CARTON
1122 g in 1 TUBE
2NDC:48783-520-081 in 1 CARTON
221.2 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(48783-520), pack(48783-520), analysis(48783-520)

Revised: 3/2014
 
Premier Dental Products Company

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