Label: ENAMELON PREVENTIVE TREATMENT- stannous fluoride gel
- NDC Code(s): 48783-500-40
- 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.
Updated December 30, 2019
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- Active ingredient
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.
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.
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
- Questions or comments?
SPL UNCLASSIFIED SECTION
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.
Clinically Proven Active Ingredient for Anticavity, Antigingivitis and Sensitive Teeth
- Relieves the discomfort of dry mouth tissues
- Non-irritating to patients with dry mouth
- Optimized with calcium and phosphate ions
- No Sodium Lauryl Sulfate (SLS), No Gluten, No Dyes
Premier® Dental Products Company, Plymouth Meeting, PA 19462
www.premusa.com Part # 9007285 www.enamelon.com
NDC 48783-500-40 021665 Rev4 SP
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ENAMELON PREVENTIVE TREATMENT
stannous fluoride gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48783-500 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.00400 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 GLYCOL, UNSPECIFIED (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 01/01/2014 1 113 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)