Label: ENAMELON- stannous fluoride paste, dentifrice
- NDC Code(s): 48783-520-08, 48783-520-43
- Packager: Premier Dental Products Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
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WARNINGS
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.
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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.
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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
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
ENAMELON
stannous fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48783-520 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.00454 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor MINT (Mint Breeze) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48783-520-43 1 in 1 CARTON 01/01/2014 1 122 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:48783-520-08 1 in 1 CARTON 01/01/2014 2 21.2 g in 1 TUBE; Type 0: Not a Combination Product 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)
